Transducer 3D9-3v 989605395622Recalls & reported problems
Philips Ultrasound LLC · Class 2
All models of Transducer 3D9-3v (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838061545), received between Nov 3, 2023 and Nov 3, 2023 — classified as 1 malfunction.
3 FDA recall records name this device's identifier, 2 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.
Reports received per month
Recalls naming this device
- Jul 3, 2025Class IIIOpen, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Z-2347-2025 · Root cause: Device Design · Recall details · FDA record ↗
- May 28, 2025Class IIOpen, Classified
Ultrasound transducer devices were refurbished beyond their useful life.
Z-2048-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jun 30, 2023Class IICompleted
Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in safety measures to prevent electric were to also fail.
Z-2517-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 3, 2023
WHEN EXAM WAS COMPLETE, PHILIPS TRANSVAGINAL PROBE BROKE IN HALF DURING ROUTINE TRANSVAGINAL EXAM, AS SONOGRAPHER WAS REMOVING PROBE FROM PATIENT. SONOGRAPHER NOTIFIED PHILIPS. THE ISSUE IS THE SAME ISSUE AS DESCRIBE IN A LARGE RECALL FOR SIMILAR DEVICES. HOWEVER, THIS PARTICULAR DEVICE IS NOT LISTED IN THE RECALL, SO PHILIPS WILL NOT COVER REPLACEMENT. MANUFACTURER RESPONSE FOR TRANSDUCER, ULTRASONIC, DIAGNOSTIC, TRANSDUCER 3D9-3V (PER SITE REPORTER). THE MANUFACTURER WILL NOT COVER COST OF REPLACEMENT OF DEVICE. THE ISSUE IS THE EXACT SAME AS DEFECTS ON A RECALL LIST, BUT THIS PARTICULAR MODEL IS NOT ON THE LIST.
Patient problems: Insufficient Information
MAUDE report 18064221 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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