Recall Z-1626-2026
Philips Ultrasound, Inc · initiated September 5, 2025
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Philips S5-2 Ultrasound Transducer
Codes / lots: Model No. 989605368393; (01)00884838064638(21)B0C824; Serial No. B0C824.
Reason for recall
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
FDA-determined cause: Device Design
Action taken
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; The expected useful life for Endocavity transducers and Transcutaneous transducers is 7 years. If a transducer has exceeded its useful life, consignees are instructed to conduct transducer performance tests or contact Philips for guidance. Consignees are asked to complete and return the provided response form and circulate the recall notification to device users for their awareness. Consignees with any questions can contact Philips Customer Care Solutions Center at 1-800-722-9377.
Details
- Recall number
- Z-1626-2026
- Initiated
- September 5, 2025
- Posted by FDA
- March 24, 2026
- Product code
- ITX – Transducer, Ultrasonic, Diagnostic
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution.
- Recalling firm
- Philips Ultrasound, Inc, Reedsville, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1618-2026 Class III | Philips 3D6-2 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 09/05/2025Open, Classified |
| Z-1619-2026 Class III | Philips C9-4 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 09/05/2025Open, Classified |
| Z-1620-2026 Class III | Philips L12-5 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 09/05/2025Open, Classified |
| Z-1621-2026 Class III | Philips L17-5 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 09/05/2025Open, Classified |
| Z-1622-2026 Class III | Philips Mini Multi TEE Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 09/05/2025Open, Classified |
| Z-1623-2026 Class III | Philips OMNI II TEE Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 09/05/2025Open, Classified |
| Z-1624-2026 Class III | Philips OMNI III TEE Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 09/05/2025Open, Classified |
| Z-1625-2026 Class III | Philips S4-1 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 09/05/2025Open, Classified |
| Z-1627-2026 Class III | Philips X3-1 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 09/05/2025Open, Classified |
| Z-1628-2026 Class III | Philips X7-2 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 09/05/2025Open, Classified |