Recall Z-1623-2026 ยท ITX Transducer, Ultrasonic, Diagnostic
Philips Ultrasound, Inc
Philips OMNI II TEE Ultrasound Transducer
| Date | Mar 24, 2026 (initiated Sep 5, 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 8/19/25, 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; Th |
| Quantity | 2 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K014191 | M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540 Philips Medical Systems, Jan 7, 2002 |