Transducer X7-2t 989605414122Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00884838061668), received between Apr 28, 2017 and Oct 17, 2024 — classified as 4 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (4 reports).

6 FDA recall records name this device's identifier, 6 still open.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 3, 2025Class IIIOpen, Classified

   To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

   Z-2412-2025 · Root cause: Device Design · Recall details · FDA record ↗

2. Jul 3, 2025Class IIIOpen, Classified

   To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

   Z-2408-2025 · Root cause: Device Design · Recall details · FDA record ↗

3. Jul 3, 2025Class IIIOpen, Classified

   To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

   Z-2395-2025 · Root cause: Device Design · Recall details · FDA record ↗

4. Jul 3, 2025Class IIIOpen, Classified

   To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

   Z-2413-2025 · Root cause: Device Design · Recall details · FDA record ↗

5. May 28, 2025Class IIOpen, Classified

   Ultrasound transducer devices were refurbished beyond their useful life.

   Z-2067-2025 · Root cause: Process control · Recall details · FDA record ↗

6. May 28, 2025Class IIOpen, Classified

   Ultrasound transducer devices were refurbished beyond their useful life.

   Z-2066-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2024

  A PATIENT WHO WAS POST-OP FROM BIOPROSTHETIC MITRAL VALVE AND TRICUSPID VALVE REPLACEMENTS WAS DECOMPENSATING FOR UNKNOWN REASONS. WE WANTED TO PERFORM A TEE (TRANSESOPHAGEAL ECHOCARDIOGRAM) TO ASSESS WHETHER THE PATIENT HAD CARDIOGENIC SHOCK IN ADDITION TO SEPTIC SHOCK. THE TEE PROBE IN THE CVICU (CARDIOVASCULAR INTENSIVE CARE UNIT) WAS SCRATCHED AND IMAGES OBTAINED WITH THE PROBE WERE NEARLY UNINTERPRETABLE. AFTER A FEW MINUTES THE PROBE STOPPED WORKING COMPLETELY. WE WERE UNABLE TO ASSESS THIS PATIENT'S RIGHT HEART FUNCTION. UNFORTUNATELY, THIS SIGNIFICANTLY DELAYED THE PATIENT GOING ON ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) AS WE NEEDED THE IMAGING TO DETERMINE WHICH CANNULA TO USE. EVENTUALLY, WE WERE ABLE TO USE A PEDIATRIC TEE PROBE (THE ONLY ONE AVAILABLE) WHICH PRODUCED SUBOPTIMAL IMAGES.

  Patient problems: Unspecified Heart Problem

  MAUDE report 20469847 ↗
• MalfunctionFeb 19, 2021Mechanical Jam; Mechanical Jam

  A CUSTOMER REPORTED AN X7-2T MODEL TRANSDUCER HAD AN ARTICULATION ISSUE DURING USE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11353257 ↗
• MalfunctionFeb 12, 2021Mechanical Jam; Mechanical Jam

  A CUSTOMER REPORTED AN X7-2T MODEL TRANSDUCER HAD AN ARTICULATION ISSUE DURING USE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11322810 ↗
• MalfunctionDec 23, 2020Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  A CUSTOMER REPORTED AN X7-2T MODEL TRANSDUCER HAD AN ARTICULATION ISSUE DURING USE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11066152 ↗
• MalfunctionDec 21, 2020Mechanical Jam; Mechanical Jam

  A CUSTOMER REPORTED AN X7-2T MODEL TRANSDUCER HAD AN ARTICULATION ISSUE DURING USE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11047809 ↗
• MalfunctionMay 26, 2020Therapeutic or Diagnostic Output Failure

  A CUSTOMER REPORTED ENCOUNTERING AN ARTICULATION ISSUE WITH THEIR X7-2T MODEL TRANSDUCER DURING A SURGICAL PROCEDURE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10089474 ↗
• MalfunctionJan 23, 2020Mechanics Altered

  A CUSTOMER REPORTED AN X7-2T MODEL TRANSDUCER HAD A LOSS OF ARTICULATION. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9624251 ↗
• MalfunctionNov 14, 2019Intermittent Energy Output

  A CUSTOMER REPORTED ENCOUNTERING AN INTERMITTENT ARTICULATION ISSUE WITH THEIR X7-2T MODEL TRANSDUCER DURING A TEE EXAMINATION. ANOTHER TRANSDUCER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE AND NO HARM WAS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9322186 ↗
• MalfunctionSep 9, 2019No Device Output

  TEE PROBE WAS INSERTED WITHOUT DIFFICULTY. AS PHYSICIAN WAS MOVING THE PROBE, THERE WAS NO PICTURE. CHANGED ULTRASOUND MACHINE AND USED SAME PROBE, AND THE SAME ISSUE REMAINED. PROBE WAS REMOVED AND ULTRASOUND MACHINE CHANGED OUT FOR A SECOND TIME. EQUIPMENT ISSUES CAUSED A DELAY IN CARE, AND THE PATIENT RECEIVED MORE SEDATION THAN HE WOULD HAVE NEEDED HAD THE EQUIPMENT BEEN WORKING.

  Patient problems: No Code Available

  MAUDE report 8974675 ↗
• InjuryJun 20, 2019Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED DETECTING A PERFORATED ESOPHAGUS AFTER PERFORMING A TRANSESOPHAGEAL (TEE) EXAMINATION USING AN X7-2T MODEL TRANSDUCER WITH AN EPIQ ULTRASOUND SYSTEM. THE PROCEDURE WAS COMPLETED WITHOUT ANY OBSERVED HARM TO THE PATIENT. THE INJURY WAS NOTICED THE NEXT DAY, AND THE PATIENT RECEIVED TREATMENT FOR THE PERFORATED ESOPHAGUS. FURTHER INFORMATION REGARDING THE PATIENT CONDITION POST PROCEDURE WAS NOT DISCLOSED AND THE DEVICE REMAINS AT THE CUSTOMER SITE.

  Patient problems: Perforation

  MAUDE report 8717966 ↗
• InjuryJun 19, 2019Difficult to Insert

  A CUSTOMER REPORTED DETECTING A PERFORATED ESOPHAGUS AFTER ATTEMPTING TO PERFORM A TRANSESOPHAGEAL (TEE) EXAMINATION USING AN X7-2T MODEL TRANSDUCER WITH AN EPIQ ULTRASOUND SYSTEM. THE DOCTOR COULD NOT PROPERLY INSERT THE TRANSDUCER DOWN THE PATIENT¿S ESOPHAGUS, SO THE PROCEDURE WAS ABORTED. THE INJURY WAS NOTICED THE NEXT DAY, AND THE PATIENT WAS TRANSPORTED TO ANOTHER FACILITY FOR TREATMENT. FURTHER INFORMATION REGARDING THE PATIENT CONDITION POST PROCEDURE WAS NOT DISCLOSED AND THE DEVICE REMAINS AT THE CUSTOMER SITE.

  Patient problems: Perforation of Esophagus

  MAUDE report 8714545 ↗
• MalfunctionJun 13, 2019Unexpected Therapeutic Results

  A CUSTOMER REPORTED ENCOUNTERING AN ARTICULATION ISSUE WITH THEIR X7-2T MODEL TRANSDUCER DURING A TRANSESOPHAGEAL (TEE) EXAMINATION. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8695879 ↗
• InjuryJun 4, 2019Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED AN INCIDENT WHERE A PATIENT SUSTAINED AN INJURY DURING AN EXAMINATION WITH AN X7-2T MODEL TRANSDUCER. UPON COMPLETION OF A TRANSESOPHAGEAL EXAM, A GASTROINTESTINAL SCOPE WAS USED TO IDENTIFY BLOOD ON THE ESOPHAGEAL WALL. FURTHER INVESTIGATION BY THE CUSTOMER FOUND THE PATIENT HAD RECEIVED AN ABRASION TO THEIR ESOPHAGUS. THE INJURY WAS TREATED TOPICALLY AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Abrasion; Injury

  MAUDE report 8667057 ↗
• MalfunctionMar 8, 2019No Display/Image

  A CUSTOMER REPORTED THEIR X7-2T MODEL TRANSDUCER WOULD NOT PRODUCE AN IMAGE DURING A DIAGNOSTIC PROCEDURE. (B)(4) LATER PROVIDED ADDITIONAL DETAILS NOTING THE PATIENT NEEDED TO STOP TAKING ANTICOAGULANTS FOR THE EXAM, AND THE DELAY IN TREATMENT CREATED AN EMBOLISM RISK FOR THE PATIENT. THE SUSPECT TRANSDUCER HAS BEEN REPLACED TO RESOLVE THE ISSUE. THE FEEDBACK DETAILS DO NOT ALLEGE THAT ANY HARM CAME TO THE PATIENT AS A RESULT OF THE INCIDENT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8405223 ↗
• MalfunctionSep 26, 2018Positioning Problem

  A CUSTOMER REPORTED AN ARTICULATION ISSUE WITH THEIR X7-2T MODEL TRANSDUCER. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7912265 ↗
• MalfunctionJul 16, 2018Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED AN X7-2T MODEL TRANSDUCER HAD AN ARTICULATION ISSUE DURING USE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7690552 ↗
• MalfunctionJun 26, 2018Communication or Transmission Problem

  A CUSTOMER REPORTED AN X7-2T MODEL TRANSDUCER HAD AN ARTICULATION ISSUE DURING USE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7638727 ↗
• InjuryMay 1, 2018Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED DETECTING A PERFORATED ESOPHAGUS AFTER PERFORMING AN EXAMINATION USING AN X7-2T MODEL TRANSDUCER WITH AN EPIQ ULTRASOUND SYSTEM. THE LOCAL FIELD SERVICE ENGINEER CONFIRMED THE CUSTOMER WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE PRIOR TO DISCOVERING THE INJURY. FURTHER INFORMATION REGARDING THE PATIENT CONDITION PRE AND POST PROCEDURE WERE NOT DISCLOSED AND THE DEVICE REMAINS AT THE CUSTOMER SITE.

  Patient problems: Perforation of Esophagus

  MAUDE report 7478334 ↗
• MalfunctionMar 5, 2018Positioning Problem

  A CUSTOMER REPORTED AN ARTICULATION ISSUE WITH THEIR X7-2T MODEL TRANSDUCER. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7313431 ↗
• MalfunctionFeb 21, 2018Positioning Problem

  A CUSTOMER REPORTED AN ARTICULATION ISSUE WITH THEIR X7-2T MODEL TRANSDUCER. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7286068 ↗
• MalfunctionApr 28, 2017Device Operates Differently Than Expected

  A CUSTOMER REPORTED AN X7-2T MODEL TRANSDUCER WAS NOT ARTICULATING PROPERLY. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6529993 ↗