Recall Z-2391-2025 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips Ultrasound, Inc
S4-1 Transducer Probe
| Date | Aug 22, 2025 (initiated Jul 3, 2025) |
| Status | Open, Classified |
| Reason | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Root cause | Device Design |
| Action | An URGENT Medical Device Correction Notice, dated 7/3/25, was mailed to consignees. This notice instructs consignees to locate all Philips Ultrasound transducers in their facility and enter their serial numbers into https://www.transducer.philips.com to obtain the manufacturing certificate for each of their devices. This certificate should be retained with its system documentation. Using the manufacturing certificate consignees are to calculate the useful life of their device. The expected useful life for Transesophageal transducers, X-Matrix transducers, and Lumify transducers is 5 years; The |
| Quantity | 171,322 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030455 | BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM Philips Ultrasound, Inc., Mar 13, 2003 |
| K120321 | CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM Philips Health Care, Feb 17, 2012 |
| K153480 | ClearVue850 Diagnostic Ultrasound System Philips Health Care, Dec 16, 2015 |
| K162549 | Lumify Ultrasound System Philips Health Care, Oct 3, 2016 |
| K192226 | Lumify Diagnostic Ultrasound System Philips Health Care, Sep 6, 2019 |