Recall Z-2068-2025 ยท ITX Transducer, Ultrasonic, Diagnostic
Philips Ultrasound, Inc
Philips XL14-3 Transducer.
| Date | Jul 2, 2025 (initiated May 28, 2025) |
| Status | Open, Classified |
| Reason | Ultrasound transducer devices were refurbished beyond their useful life. |
| Root cause | Process control |
| Action | An URGENT Medical Device Recall notification dated 5/28/25 was mailed to consignees. The notification informs consignees that Philips Ultrasound will be replacing transducers that were refurbished beyond their useful life with a new transducer. Consignees may continue to use affected devices while awaiting replacement; consignees should use devices in accordance with their intended use and per the instructions provided int he User Manual. Users should perform visual inspection and electrical safety testing as indicated in the User Manual; if a device does not pass inspection, it should be remo |
| Quantity | 5,230 units |
| Distribution | Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172607 | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound Syst Philips Health Care, Oct 4, 2017 |
| K181485 | EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System Philips Ultrasound, Inc., Jul 27, 2018 |
| K182857 | EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Philips Ultrasound, Inc., Nov 9, 2018 |
| K202216 | EPIQ Series Diagnostic Ultrasound Systems Philips Ultrasound, Inc., Sep 2, 2020 |
| K250030 | Flash Ultrasound System 5100 Point of Care Philips Ultrasound, LLC, Apr 28, 2025 |