Transducer X8-2t 989605455171Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00884838069718), received between Jun 27, 2018 and Aug 6, 2025 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Defective Device” (3 reports).

8 FDA recall records name this device's identifier, 8 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-2352-2025 · 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-2412-2025 · 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-2350-2025 · 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-2408-2025 · Root cause: Device Design · Recall details · FDA record ↗

5. 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 ↗

6. Jul 3, 2025Class IIIOpen, Classified

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

   Z-2409-2025 · Root cause: Device Design · Recall details · FDA record ↗

7. 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 ↗

8. 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN EPIQ CVX ULTRASOUND SYSTEM AND TRANSESOPHAGEAL X8-2T TRANSDUCER WERE USED FOR MONITORING DURING A SINGLE LUNG TRANSPLANT CASE ON A PATIENT. DAYS AFTER THE PROCEDURE TOOK PLACE, AN ESOPHAGEAL PERFORATION WAS REPORTED. THE INJURY TO THE ESOPHAGUS WAS REPAIRED SURGICALLY AND PATIENT RECOVERED IN THE HOSPITAL. THERE ARE NO INITIAL INDICATIONS OF A MALFUNCTION, HOWEVER, PHILIPS HAS STARTED AN INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION.

  Patient problems: Perforation of Esophagus

  MAUDE report 22725946 ↗
• MalfunctionAug 5, 2024

  SITUATION: TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PROBE RUBBER SHEATH WAS NOT INTACT WHEN PROBE REMOVED FROM PATIENT¿S ESOPHAGUS AT THE END OF PROCEDURE. TEE PROBE WAS INTACT PRIOR TO INSERTION. BACKGROUND: PATIENT UNDERWENT ROUTINE TEE WITH BITE BLOCK IN PLACE. WHEN PROBE WAS REMOVED AND CARDIOLOGIST PASSED THE PROBE TO ECHO TECH, SHE WIPED IT DOWN AS PER USUAL PRACTICE AND SHE NOTED A 1-1.5¿ PIECE OF THE PROBE COVERING (BLACK, SOFT RUBBER) WAS MISSING. SHE NOTIFIED THE CARDIOLOGIST AND THE REGISTERED NURSE (RN) WHO WERE ALSO AT BEDSIDE AND ALL LOOKED FOR THE PIECE IN THE BED, TRASH, LINEN, ETC. THE MISSING PIECE WAS NOT FOUND. THE PATIENT HAD A CT SCAN AND RESULTS DO NOT SHOW ANY ¿DISCERNABLE RADIOPAQUE FOREIGN OBJECT¿ OR EVIDENCE OF BOWEL OBSTRUCTION. THE TEE PROBE WAS SEQUESTERED AND SUBSEQUENTLY, BIOMED TOOK POSSESSION OF THE PROBE WITH INTENT ON SENDING BACK TO PHILIPS.

  Patient problems: Foreign Body In Patient

  MAUDE report 19905412 ↗
• MalfunctionMay 28, 2021Unexpected Shutdown; Application Program Freezes or Fails to Launch; Unexpected Shutdown; Application Program Freezes or Fails to Launch

  A CUSTOMER REPORTED ENCOUNTERING AN INCIDENT WHERE THEIR EPIQ 7C ULTRASOUND SYSTEM BECAME UNRESPONSIVE DURING A MITRA CLIP HEART VALVE PROCEDURE. THE SYSTEM WAS RESTARTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT WAS NOT HARMED AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11903597 ↗
• MalfunctionFeb 12, 2021Mechanical Jam; Mechanical Jam

  A CUSTOMER REPORTED AN X8-2T 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 11322785 ↗
• MalfunctionJan 13, 2021Mechanical Jam; Mechanical Jam

  A CUSTOMER REPORTED AN X8-2T MODEL TRANSDUCER WOULD NOT ARTICULATE WITH HAND CONTROLS DURING USE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11158791 ↗
• MalfunctionOct 15, 2020Positioning Failure; Mechanical Jam; Positioning Failure; Mechanical Jam

  A CUSTOMER REPORTED AN X8-2T MODEL TRANSDUCER HAD AN ARTICULATION ISSUE PREVENTING TIP MOTION. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10684098 ↗
• MalfunctionOct 7, 2020Positioning Failure; Positioning Failure

  A CUSTOMER REPORTED AN X8-2T MODEL TRANSDUCER HAD AN ARTICULATION ISSUE PREVENTING FORWARD AND BACKWARD MOTION. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10641424 ↗
• MalfunctionMay 1, 2020Mechanical Problem

  A CUSTOMER REPORTED AN X8-2T MODEL TRANSDUCER HAD A PARTIAL LOSS OF ARTICULATION DURING USE. THE PROCEDURE IN PROGRESS WAS COMPLETED SUCCESSFULLY WITH NO NEGATIVE PATIENT OUTCOME. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10017640 ↗
• MalfunctionMar 19, 2020Therapeutic or Diagnostic Output Failure

  A CUSTOMER REPORTED AN X8-2T MODEL TRANSDUCER HAD LIMITED SIDE TO SIDE ARTICULATION. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9857191 ↗
• MalfunctionFeb 11, 2020Activation, Positioning or Separation Problem

  A CUSTOMER REPORTED A LOSS OF ARTICULATION WITH THEIR X8-2T MODEL TRANSDUCER. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9693960 ↗
• MalfunctionJan 2, 2020Mechanical Problem

  A CUSTOMER REPORTED THEIR X8-2T 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 9540599 ↗
• MalfunctionDec 19, 2019Defective Device

  A CUSTOMER REPORTED THEIR X8-2T MODEL TRANSDUCER HAD A LOSS OF ARTICULATION MOVEMENT ONE DIRECTION. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492216 ↗
• MalfunctionDec 9, 2019Failure to Sense

  A CUSTOMER REPORTED ENCOUNTERING AN INCIDENT WHERE THEIR EPIQ ULTRASOUND SYSTEM WOULD NOT RECOGNIZE THE X8-2T TEE MODEL TRANSDUCER DURING AN ELECTIVE AORTIC VALVE REPLACEMENT. THE FAILURE OCCURRED WHILE THE TRANSDUCER WAS INSERTED IN THE PATIENT, BUT PRIOR TO THE BYPASS SURGERY. AFTER REBOOTING THE SYSTEM TWICE, THE TRANSDUCER BECAME FULLY FUNCTIONAL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9440524 ↗
• MalfunctionNov 4, 2019Defective Device

  A CUSTOMER REPORTED ENCOUNTERING AN ARTICULATION ISSUE WITH THEIR X8-2T MODEL TRANSDUCER DURING A TEE EXAMINATION. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9274694 ↗
• MalfunctionOct 10, 2019Defective Device

  A CUSTOMER REPORTED ENCOUNTERING AN ARTICULATION ISSUE WITH THEIR X8-2T MODEL TRANSDUCER DURING A TEE EXAMINATION. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9176705 ↗
• InjuryMay 17, 2019Device Contamination with Body Fluid

  A CUSTOMER REPORTED ENCOUNTERING AN INCIDENT WHERE A PATIENT SUSTAINED AN INJURY DURING AN EXAMINATION WITH AN X8-2T MODEL TRANSDUCER. UPON COMPLETION OF A TRANSESOPHAGEAL ECHOCARDIOGRAM STUDY, BLOOD WAS FOUND ON THE TRANSDUCER AS IT WAS WITHDRAWN FROM THE PATIENT. FURTHER INVESTIGATION FOUND THE PATIENT HAD RECEIVED A LACERATION TO THEIR ESOPHAGUS. THE INJURY WAS TREATED MEDICALLY AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 8621810 ↗
• MalfunctionApr 4, 2019Positioning Problem

  A CUSTOMER REPORTED ENCOUNTERING AN ARTICULATION ISSUE WITH THEIR X8-2T MODEL TRANSDUCER DURING A TEE EXAMINATION. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8485353 ↗
• MalfunctionJan 15, 2019Mechanical Problem

  A CUSTOMER REPORTED AN ARTICULATION ISSUE WITH THEIR X8-2T MODEL TRANSDUCER. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8249860 ↗
• MalfunctionJun 27, 2018Communication or Transmission Problem

  A CUSTOMER REPORTED AN ARTICULATION ISSUE WITH THEIR X8-2T MODEL TRANSDUCER. THE TRANSESOPHAGEAL (TEE) TRANSDUCER WAS USED IN CONJUNCTION WITH AN ENDOTRACHEAL TUBE FOR THIS EXAMINATION. THE PHYSICIAN COULD NOT PASS THE X8-2T BY THE ENDOTRACHEAL TUBE DUE TO THE LACK OF THE TRANSDUCER¿S FULL ARTICULATION CAPABILITIES. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER TRANSDUCER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7643573 ↗