Situate 01-0031Recalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 10884521700642), received between Sep 27, 2017 and Jul 3, 2025 — classified as 11 injuries, 86 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (68 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT PRIOR TO USE, THE MAT WAS DETECTING EVEN WHEN NOTHING WAS ON IT. "DETECTION WITHOUT X-RAY ITEM". THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395078 ↗
• MalfunctionMay 21, 2025False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER THE BODY SCANNER ALERTED FOR A POTENTIAL SPONGE, BUT IT WAS CONFIRMED INCORRECT WHEN CHECKED WITH AN ALTERNATE CONSOLE WAND AND REAPPLICATION OF THE DEVICE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059393 ↗
• MalfunctionApr 21, 2025False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, THE BODY SCANNER WAS DETECTING EVEN WITHOUT PAD ON PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 21875303 ↗
• MalfunctionApr 21, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT THE MAT ALARMS EVEN WHEN NO OBJECT WAS PRESENT.

  Patient problems: Insufficient Information

  MAUDE report 21875184 ↗
• InjuryApr 10, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT POST-OPERATIVELY, A NON-MEDTRONIC LAPAROTOMY SPONGE WAS RETAINED IN THE PATIENT FOLLOWING A SURGICAL PROCEDURE, NECESSITATING A SECOND SURGERY TO RETRIEVE THE SPONGE. THE RETAINED SPONGE RESULTED IN EXTENDED THE PATIENT'S HOSPITALIZATION BY 3-4 DAYS. AN X-RAY WAS TAKEN TO ASSIST IN LOCATING THE RETAINED SPONGE. AND THE PATIENT WAS INITIALLY TAKEN TO THE INTENSIVE CARE UNIT BUT HAD TO RETURN DUE TO COMPLICATIONS. THE SPONGE WAS FULLY RETRIEVED DURING THE SECOND SURGERY. IT WAS NOTED THAT THE SPONGE COUNT WAS CORRECT AND MACHINE READ A CORRECT COUNT AT THE END OF THE INITIAL PROCEDURE BUT DID NOT DETECT A SPONGE WAS IN THE PATIENT.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 21819004 ↗
• InjuryApr 4, 2025False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, DURING DEBRIDEMENT, THE BODY SCANNER WAS USED HAD A DETECTION BUT THE COUNTS WERE CORRECT. THE WAND WAS USED AND IT DEEMED EVERYTHING CLEAR. HOWEVER, THE REPORTER WAS NOT SATISFIED WITH THAT BECAUSE THE PATIENT HAD A PREVIOUS SURGERY IN [REDACTED]. CALLED THE FRONT AND WAS ADVISED THAT IT WOULD BE SAFE TO GET AN X-RAY. THE X-RAY WAS COMPLETED AND DID NOT SHOW ANYTHING RETAINED. AT THE END OF THE CASE WHEN THE PATIENT WAS MOVED AND CHECKED THE BODY SCANNER AGAIN IT SHOWED CLEAR WHICH STILL HAD THE REPORTER CONCERN. THAT WAS REMOVED AND TAGGED AND PLACED AT THE FRONT DESK AT THE END OF THE FOLLOWING PATIENT CASE TO WHICH THE MAT DID THE SAME THING. IF THE BIOMED CHECKS THIS MAT IT MAY APPEAR OK UNTIL THE PATIENT IS ON THE MAT WHICH WILL SHOW DETECTION AGAIN.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21774828 ↗
• InjuryJan 20, 2025False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, DURING PROCEDURE, AS SURGERY WAS BEING WRAPPED-UP, THE SCANNING DEVICES WAS KEPT GETTING FLIP-FLOPPED RESULTS OF CLEAR VS DETECTION AS SOMETHING BETWEEN THE MAT AND WAND WAS COMING UP UNCLEAR. MAT WAS SAYING "DETECTION" AND WAND WAS NOT DETECTING ANYTHING. THEY NEEDED TO ORDER AN X-RAY TO DETERMINE FINAL DIAGNOSTICS. X-RAY WAS NEGATIVE. THERE WAS UNNECESSARY RADIATION DUE TO PROLONGED USE OF PRODUCT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21191519 ↗
• MalfunctionJan 13, 2025False Negative Result; Device Displays Incorrect Message; False Negative Result; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE BODY SCANNER HAD FALSE SCAN SIGN WHEN CONNECTED AT TESTED TO SCAN. THE ERROR MESSAGE WAS ACTUALLY ELECTRICAL FAULT ERROR, BIOMED TESTED MAT WITH A NEW CONSOLE AND SAME FALSE SCAN OCCURRED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21142968 ↗
• MalfunctionSep 18, 2024False Negative Result; Material Integrity Problem; False Negative Result; Material Integrity Problem

  ACCORDING TO THE REPORTER, WIRES EXPOSED AND GAVE FALSE READINGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251286 ↗
• MalfunctionJun 26, 2024False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE BODY SCANNER HAD FALSE DETECTION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19620924 ↗
• InjuryJun 18, 2024False Positive Result; Insufficient Device Problem Information; False Positive Result; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ADRENALECTOMY. INITIALLY, THE RF MAT WAS UNINTENTIONALLY FOLDED DURING POSITIONING. AFTER THE CASE, THE MAT WAS USED BUT IT SHOWED DETECTION EVEN WHEN THE SPONGE COUNTS WERE CORRECT WITH RF MACHINE X18ASQ. A REPLACEMENT MACHINE WAS USED X18AOY WITH THE SAME MAT WHICH ALSO REVEALED DETECTION. THE STAFF USED THE WAND WHICH CLEARED THE COUNT BUT PER POLICY, AN X-RAY WAS TAKEN (NEGATIVE) WHICH DELAYED THE CASE. THE MAT WAS CHECKED WHICH RESULTED IN CLEAR READING. ON THE NEXT CASEWITH THE SAME PATIENT, PATIENT WAS ON SUPINE, SO THE SAME MAT WAS USED. AFTER THE CASE, THE COUNT WAS CORRECT BUT WHEN THE MAT WAS USED, IT REVEALED DETECTION AGAIN. THE STAFF USED THE WAND TO VERIFY THE COUNT AND THE MACHINE X18AOY CLEARED THE READING. SPONGE, NEEDLE AND INSTRUMENT COUNTS WERE REPORTED TO BE CORRECT X 2 AND ALL RFA INTACT. ONE RFA DETECTION WAS CLEAR BUT THE OTHER(MAT) WAS PO SITIVE. XRAYS WERE NEGATIVE FOR RETAINED FOREIGN BODY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 19561144 ↗
• InjuryJun 18, 2024False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ADRENALECTOMY. INITIALLY, THE RF MAT WAS UNINTENTIONALLY FOLDED DURING POSITIONING. AFTER THE CASE, THE MAT WAS USED BUT IT SHOWED DETECTION EVEN WHEN THE SPONGE COUNTS WERE CORRECT WITH RF MACHINE X18ASQ. A REPLACEMENT MACHINE WAS USED X18AOY WITH THE SAME MAT WHICH ALSO REVEALED DETECTION. THE STAFF USED THE WAND WHICH CLEARED THE COUNT BUT PER POLICY, AN X-RAY WAS TAKEN (NEGATIVE) WHICH DELAYED THE CASE. THE MAT WAS CHECKED WHICH RESULTED IN CLEAR READING. ON THE NEXT PROCEDURE WITH THE SAME PATIENT, PATIENT WAS ON SUPINE POSITION AND THE SAME MAT WAS USED. AFTER THE CASE, THE COUNT WAS CORRECT BUT WHEN THE MAT WAS USED, IT REVEALED DETECTION AGAIN. THE STAFF USED THE WAND TO VERIFY THE COUNT AND THE MACHINE X18AOY CLEARED THE READING. SPONGE, NEEDLE AND INSTRUMENT COUNTS WERE REPORTED TO BE CORRECT TWICE AND ALL RFA INTACT. EVENTUALLY, ONE OF THE MAT WAS MALFU NCTIONING WHICH HAD CLEAR DETECTION BUT THE OTHER(MAT) WAS POSITIVE. XRAYS WERE NEGATIVE FOR RETAINED FOREIGN BODY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 19561046 ↗
• MalfunctionMay 1, 2024False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE MAT WAS DETECTING FALSE POSITIVES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221638 ↗
• MalfunctionMar 14, 2024False Positive Result; Electromagnetic Compatibility Problem; False Positive Result; Electromagnetic Compatibility Problem

  ACCORDING TO REPORTER, DURING A BREAST PROCEDURE, DEVICE¿S COUNT WAS DETERMINED CORRECT MULTIPLE TIMES MANUALLY. THE SITUATE WAND WAS USED TO VALIDATE CLEAR CODE AND PROPER COUNT #. IT WAS THEN USED AS AN ADJUNCT AND SHOWED A DETECTION, ALTHOUGH NO COTTON WAS LEFT BEHIND. (FALSE POSITIVE). STERIS 4085 BED POTENTIALLY CAUSING ELECTRICAL NOISE LEAKAGE CAUSING INTERFERENCE WITH MAT. MAT WAS RAN AGAIN AND GAVE FALSE POSITIVE. THE OLD MAT WAS REPLACED BY A NEW MAT. THE NEW MAT WAS NOT TESTED AT THE TIME. THE HOSPITAL IS UTILIZING THE WAND ATTACHMENT WITH THE CONSOLE CURRENTLY WITH NO ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 18906008 ↗
• MalfunctionMar 7, 2024False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, DEVICE HAD FALSE POSITIVE DETECTION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862719 ↗
• MalfunctionNov 3, 2023False Positive Result; False Positive Result

  ACCORDING TO REPORTER, DURING PROCEDURE, DEVICE SHOWED DETECTED BUT NOT THERE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18068436 ↗
• MalfunctionSep 13, 2023False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, AFTER INCISION AND DRAINAGE OF LEFT BREAST; REMOVAL/REPLACEMENT OF BREAST IMPLANT WAS COMPLETED, SURGICAL TEAM USED THE SITUATE MAT TO SCAN FOR LAP SPONGES. THE UNIT KEPT ALARMING THAT IT DETECTED A SPONGE MULTIPLE TIMES. SPONGE COUNT WAS REPEATED THREE TIMES AND ALL SPONGES WERE ACCOUNTED FOR. THE TEAM THEN USED THE SITUATE HAND WAND AND IT READ ALL CLEAR. THIS WAS REPEATED THREE TIMES ALSO. THE ATTENDING SURGEON WAS IN THE ROOM AND NOTED DEVICE HAD SAME ISSUE DAY PRIOR.

  Patient problems: Insufficient Information

  MAUDE report 17736110 ↗
• MalfunctionSep 5, 2023False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, DURING EXPLORATORY LAPAROTOMY, WHILE DOING PATIENT MAT SCAN, THE MAT DISPLAYED A DETECTION SCREEN ON THE CONSOLE. THE STAFF WAS UNABLE TO LOCATE ANY SPONGES AND THE COUNT WAS CORRECT. ANOTHER MAT SCAN WAS COMPLETED BUT STILL DISPLAYED A POSITIVE DETECTION WITH THE MAT ON THE BED. THE PATIENT AREA WAS INSPECTED AND ALL EQUIPMENT AND METAL WAS REMOVED FURTHER, THE PATIENT TWITCH MONITOR WAS MOVED FURTHER AWAY AND TURNED OFF, AND THE MAT STILL DID NOT PRESENT A CLEAR SCAN. THE RF WAND WAS USED TO COMPLETE THE NEXT SCAN AND A CLEAR SCAN WAS OBTAINED. A NEW MAT WAS ALSO BROUGHT INTO THE SAME OR AND PLACED ON THE SAME BED AND A CLEAR SCAN WAS THEN OBTAINED USING THE SAME CONSOLE AND CORD WITH THE NEW MAT. THE ORIGINAL RF MAT PRESENTING THE FALSE DETECTION WAS THEN TESTED OUTSIDE THE OR AREA USING A NEW MACHINE AND A NEW MAT CABLE AND THE RF MAT STILL DISPLAYED A FALSE POSITIVE DETECTION.  THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17685856 ↗
• MalfunctionAug 31, 2023False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, AFTER INCISION AND DRAINAGE OF LEFT BREAST, REMOVAL/REPLACEMENT OF BREAST IMPLANT WAS COMPLETED. THE SURGICAL TEAM USED THE SITUATE MAT TO SCAN FOR LAP SPONGES. THE UNIT KEPT ALARMING THAT IT DETECTED A SPONGE MULTIPLE TIMES. THE SPONGE COUNT WAS REPEATED THREE TIMES AND ALL SPONGES WERE ACCOUNTED FOR. THE TEAM THEN USED THE SITUATE HAND WAND AND IT READ ALL CLEAR. THIS WAS REPEATED THREE TIMES ALSO. THE ATTENDING SURGEON WAS IN THE ROOM AND NOTED THE DEVICE HAD THE SAME ISSUE THE DAY PRIOR.

  Patient problems: Insufficient Information

  MAUDE report 17667527 ↗
• MalfunctionAug 4, 2023False Negative Result; Defective Device; False Negative Result; Defective Device

  ACCORDING TO THE REPORTER THE DEVICE WAS NOT SCANNING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17465987 ↗
• MalfunctionJul 25, 2023False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE MAT PRODUCING FALSE DETECTIONS. IT WAS USED WITH CONSOLE, THEY USED THE MAT TO SCAN FOR LAP SPONGES. THE UNIT KEPT ALARMING THAT IT DETECTED A SPONGE MULTIPLE TIMES. SPONGE COUNT WAS REPEATED THREE TIMES AND ALL WERE ACCOUNTED FOR. THEY GRABBED THE HAND WAND FOR THE MAT AND IT READ ALL CLEAR. IT WAS REPEATED THREE TIMES ALSO. THE DOCTOR WAS IN THE ROOM, THEY SAID THAT THE SAME THING HAPPENED IN THE ROOM THE OTHER DAY AND THE MAT SHOULD HAVE BEEN REMOVED FROM SERVICE. THE MAT WAS REMOVED FROM BED AND BROUGHT TO CONTROL DESK AT END OF CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17389629 ↗
• MalfunctionJun 5, 2023False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS DETECTING SPONGE WHEN NO SPONGE WAS THERE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17061607 ↗
• MalfunctionApr 3, 2023False Negative Result; False Negative Result

  ACCORDING TO THE REPORTER, DURING EXPLORATORY LAPAROTOMY CHOLIANGIOGRAM T-TUBE PLACEMENT, OVERSEW DUCT INJURY WITH T-TUBE, REPLACEMENT OF G-TUBE; ESOPHAGOGASTRODUODENOSCOPY; FLEXIBLE BRONCHOSCOPY PROCEDURE, CLOSING COUNT WAS INCORRECT. STAFF SCANNED PATIENT WITH SITUATE MAT AND RECEIVED ¿ALL CLEAR¿ MESSAGE. STAFF THEN USED SITUATE WAND ON FIELD AND LAP PAD DETECTED. SURGEON HAD TOWEL TOWARDS HEAD OF BED; ONCE TOWEL LIFTED, A LAP PAD WAS IDENTIFIED AND RETRIEVED. CONCERN THAT SITUATE MAT DID NOT DETECT LAP PAD THAT WAS DETECTED BY SITUATE WAND. DURING THE CASE IN WHICH THIS INCIDENT OCCURRED, THE WAND WAS SUCCESSFULLY DETECTING THE SPONGE WHERE AS MAT WAS NOT. AFTER THE CASE, THE SAME CONSOLE WAS TESTED WITH THE SAME MAT CORD AND A DIFFERENT MAT, AND DETECTION WAS ACHIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16667669 ↗
• MalfunctionApr 3, 2023False Negative Result; Insufficient Device Problem Information; False Negative Result; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE MAT WOULD NOT DETECT A SPONGE WITHIN RANGE. SCANNED PATIENT WITH SITUATE MAT AND RECEIVED ¿ALL CLEAR¿ MESSAGE THEN USED SITUATE WAND ON FIELD AND LAP PAD WAS DETECTED. PUT TOWEL TOWARDS HEAD OF BED, ONCE TOWEL WAS LIFTED, A LAP PAD WAS IDENTIFIED AND RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16665302 ↗
• MalfunctionNov 9, 2022False Negative Result; False Positive Result; False Negative Result; False Positive Result

  ACCORDING TO THE REPORTER, THE MAT DID NOT DETECT SPONGES. THE DEVICE GAVE A "DETECTION" MESSAGE WHEN THERE WERE NO RF TAGGED SPONGES PRESENT IN THE SCAN AREA AND GAVE A GREEN ¿CLEAR¿ OR ¿SCAN COMPLETE¿ MESSAGE WHEN SPONGES WERE STILL PRESENT IN THE SCANNING AREA. USED ANOTHER MAT AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759125 ↗