Transducer S7-3t 989605406772Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00884838061439), received between Aug 3, 2017 and Dec 10, 2020 — classified as 1 death, 5 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (4 reports).

5 FDA recall records name this device's identifier, 5 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-2395-2025 · Root cause: Device Design · Recall details · FDA record ↗

3. May 28, 2025Class IIOpen, Classified

   Ultrasound transducer devices were refurbished beyond their useful life.

   Z-2060-2025 · Root cause: Process control · Recall details · FDA record ↗

4. 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 ↗

5. May 28, 2025Class IIOpen, Classified

   Ultrasound transducer devices were refurbished beyond their useful life.

   Z-2061-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2020Mechanical Jam; Mechanical Jam

  A CUSTOMER REPORTED AN S7-3T 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 10984036 ↗
• InjuryOct 23, 2020Positioning Problem

  A CUSTOMER REPORTED ENCOUNTERING AN INCIDENT WITH THEIR S7-3T TRANSESOPHAGEAL TRANSDUCER DURING A PEDIATRIC SURGICAL PROCEDURE FOR CONGENITAL HEART DISEASE. THE PATIENT¿S UPPER LIP PRESENTED AN APPARENT SMALL BURN WHERE THE TRANSDUCER WAS POSITIONED. THIS ISSUE DID NOT IMPACT THE OUTCOME OF THE PROCEDURE.

  Patient problems: Burn, Thermal

  MAUDE report 10726602 ↗
• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED ENCOUNTERING AN INCIDENT WITH THEIR S7-3T TRANSESOPHAGEAL TRANSDUCER DURING A PEDIATRIC SURGICAL PROCEDURE FOR CONGENITAL HEART DISEASE. THE PATIENT¿S UPPER LIP PRESENTED AN APPARENT SMALL BURN WHERE THE TRANSDUCER WAS POSITIONED. THIS ISSUE DID NOT IMPACT THE OUTCOME OF THE PROCEDURE.

  Patient problems: Burn, Thermal

  MAUDE report 10345367 ↗
• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED ENCOUNTERING AN INCIDENT WITH THEIR S7-3T TRANSESOPHAGEAL TRANSDUCER DURING A PEDIATRIC SURGICAL PROCEDURE FOR CONGENITAL HEART DISEASE. THE PATIENT¿S UPPER LIP PRESENTED AN APPARENT SMALL BURN WHERE THE TRANSDUCER WAS POSITIONED. THIS ISSUE DID NOT IMPACT THE OUTCOME OF THE PROCEDURE.

  Patient problems: Burn, Thermal

  MAUDE report 10345311 ↗
• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED ENCOUNTERING AN INCIDENT WITH THEIR S7-3T TRANSESOPHAGEAL TRANSDUCER DURING A PEDIATRIC SURGICAL PROCEDURE FOR CONGENITAL HEART DISEASE. THE PATIENT¿S UPPER LIP PRESENTED AN APPARENT SMALL BURN WHERE THE TRANSDUCER WAS POSITIONED. THIS ISSUE DID NOT IMPACT THE OUTCOME OF THE PROCEDURE.

  Patient problems: Burn, Thermal

  MAUDE report 10345272 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED ENCOUNTERING AN INCIDENT WITH THEIR S7-3T TRANSESOPHAGEAL TRANSDUCER DURING A PEDIATRIC SURGICAL PROCEDURE FOR CONGENITAL HEART DISEASE. THE PATIENT¿S UPPER LIP PRESENTED AN APPARENT SMALL BURN WHERE THE TRANSDUCER WAS POSITIONED. THIS ISSUE DID NOT IMPACT THE OUTCOME OF THE PROCEDURE.

  Patient problems: Burn, Thermal

  MAUDE report 10251806 ↗
• MalfunctionApr 1, 2020Activation Problem

  A CUSTOMER REPORTED AN S7-3T MODEL TRANSDUCER HAD NO ARTICULATION IN ONE DIRECTION. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9912281 ↗
• MalfunctionAug 19, 2019Therapeutic or Diagnostic Output Failure

  A CUSTOMER REPORTED AN S7-3T MODEL TRANSDUCER WAS NOT REGISTERING A PATIENT TEMPERATURE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8907623 ↗
• MalfunctionJun 21, 2019Temperature Problem

  A CUSTOMER REPORTED AN S7-3T MODEL TRANSDUCER DISPLAYING A TIP TEMPERATURE OF ZERO DEGREES CELSIUS. THE DISCOVERY WAS MADE DURING INSTALLATION AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8724809 ↗
• MalfunctionJun 21, 2019Temperature Problem

  A CUSTOMER REPORTED AN S7-3T MODEL TRANSDUCER DISPLAYING A TIP TEMPERATURE OF ZERO DEGREES CELSIUS. THE DISCOVERY WAS MADE DURING INSTALLATION AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8724671 ↗
• MalfunctionJun 21, 2019Temperature Problem

  A CUSTOMER REPORTED AN S7-3T MODEL TRANSDUCER DISPLAYING A TIP TEMPERATURE OF ZERO DEGREES CELSIUS. THE DISCOVERY WAS MADE DURING INSTALLATION AND THERE WAS NO PATIENT INVOLVEMENT. 3019216-2019/08/28-002-R.

  Patient problems: No Patient Involvement

  MAUDE report 8724479 ↗
• MalfunctionJun 21, 2019Temperature Problem

  A CUSTOMER REPORTED AN S7-3T MODEL TRANSDUCER DISPLAYING A TIP TEMPERATURE OF ZERO DEGREES CELSIUS. THE DISCOVERY WAS MADE DURING INSTALLATION AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8724407 ↗
• MalfunctionJun 21, 2019Display or Visual Feedback Problem

  A CUSTOMER REPORTED AN S7-3T MODEL TRANSDUCER DISPLAYING A TIP TEMPERATURE OF ZERO DEGREES CELSIUS. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8724321 ↗
• MalfunctionJun 21, 2019Display or Visual Feedback Problem

  A CUSTOMER REPORTED AN S7-3T MODEL TRANSDUCER DISPLAYING A TIP TEMPERATURE OF ZERO DEGREES CELSIUS. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8724103 ↗
• MalfunctionApr 22, 2019Positioning Problem

  A CUSTOMER REPORTED ENCOUNTERING AN ARTICULATION ISSUE WITH THEIR S7-3T MODEL TRANSDUCER DURING A TEE (TRANSESOPHAGEAL) EXAMINATION. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8536903 ↗
• DeathJul 23, 2018Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED AN S7-3T MODEL TRANSDUCER PERFORATED A NEONATAL ESOPHAGUS WHILE UNDERGOING HEART SURGERY. DURING THE PROCEDURE THE PATIENT EXPIRED.

  Patient problems: Death; Perforation of Esophagus

  MAUDE report 7709994 ↗
• MalfunctionMar 14, 2018Detachment Of Device Component; Crack

  A CUSTOMER REPORTED THAT WHILE PERFORMING A PROCEDURE WITH AN S7-3T MODEL TRANSDUCER, A PORTION OF THE PROBE¿S TIP CRACKED AND THE BENDING NECK SHEATH BEGAN TO DETACH FROM THE DEVICE. THE TRANSDUCER WAS PROMPTLY REMOVED FROM THE PATIENT¿S THROAT WITH NO PART OF THE PROBE REMAINING IN THE PATIENT. THE SITE¿S PHILIPS FIELD SERVICE ENGINEER CONFIRMED THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT. THE SUSPECT TRANSDUCER HAS BEEN REMOVED FROM SERVICE AND WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7339526 ↗
• MalfunctionAug 3, 2017Crack

  A CUSTOMER REPORTED THAT WHILE PERFORMING A PROCEDURE WITH AN S7-3T MODEL TRANSDUCER, A PORTION OF THE PROBE¿S TIP CRACKED AND BEGAN TO DETACH FROM THE DEVICE. THE TRANSDUCER WAS PROMPTLY REMOVED FROM THE PATIENT¿S THROAT WITH NO PART OF THE PROBE REMAINING IN THE PATIENT. THE SITE¿S PHILIPS FIELD SERVICE ENGINEER CONFIRMED THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT. THE SUSPECT TRANSDUCER HAS BEEN REMOVED FROM SERVICE AND WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6765648 ↗