Z-1627-2026 Class III Ongoing
FDA device recall Z-1627-2026 was initiated by Philips Ultrasound, Inc on September 5, 2025 and is designated Class III. Reason for recall: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. The recall status is ongoing. Affected quantity: 17 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2026
- Initiation Date
- September 5, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 units
Product Description
Philips X3-1 Ultrasound Transducer
Reason for Recall
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Distribution Pattern
US Nationwide distribution.
Code Information
Model No. 989605440742, 989603002321, 989605388101, 989605440741; UDI: (01)00884838067615(21)033TVZ, (01)00884838067615(21)02Q8R3, (01)00884838067615(21)02VLZV, (01)00884838067615(21)02WND0, (01)00884838067615(21)02ZWBH, (01)00884838067615(21)02GP3C, (01)00884838067615(21)03DTL6, (01)00884838067615(21)02JK1H, (01)00884838067615(21)02VMJ6, (01)00884838067615(21)035Z89, (01)00884838067615(21)031C21, (01)00884838067615(21)02JL3W, (01)00884838067615(21)03C066, (01)00884838067615(21)02JK8D; Serial No. 033TVZ, 02Q8R3, 02VLZV, 02WND0, 02ZWBH, 02GP3C, 02YHTG, 02YHPN, 03DTL6, 02JK1H, 02VMJ6, 035Z89, 031C21, 038NQC, 02JL3W, 03C066, 02JK8D.