Philips X7-2 ultrasound transducers recalled for clarification on useful life labelling
Philips is clarifying and updating labelling on certain X7-2 ultrasound transducers to better define their useful life in the field. This affects a small number of units distributed nationwide. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Philips recalls
What to do
- If you operate one of the affected serial numbers (03FG1T, 031LM2, 032Q7G, 0344RZ, 033VM9), contact Philips for updated labelling or guidance
- Refer to the updated labelling for proper useful life information before clinical use
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Philips X7-2 Ultrasound Transducer
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 11 products — see all of them.
Details
- Units affected
- 5 units
- Illnesses reported
- None reported
- Manufactured in
- 1 Echo Dr, Reedsville, PA, United States
- Classification
- Class III
- Recall number
- Z-1628-2026
In the FDA's words
- Description
- Philips X7-2 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Model No. 989605388121, 989605347571, 989605347573; UDI: (01)00884838061729(21)0344RZ; Serial No. 03FG1T, 031LM2, 032Q7G, 0344RZ, 033VM9. Distribution: US Nationwide distribution. Affected quantity: 5 units
- Hazard
- To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
11 products in this recall
Philips ultrasound transducers recalled for unclear useful-life labeling
Philips is recalling 11 ultrasound transducer models to clarify and update labeling that defines how long these devices are expected to remain in use. The recall was filed for clarification, and no injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Philips 3D6-2 Ultrasound TransducerZ-1618-2026 · 17 units
- Philips C9-4 Ultrasound TransducerZ-1619-2026 · 1 unit
- Philips L12-5 Ultrasound TransducerZ-1620-2026 · 40 units
- Philips L17-5 Ultrasound TransducerZ-1621-2026 · 2 units
- Philips Mini Multi TEE Ultrasound TransducerZ-1622-2026 · 11 units
- Philips OMNI II TEE Ultrasound TransducerZ-1623-2026 · 2 units
- Philips OMNI III TEE Ultrasound TransducerZ-1624-2026 · 75 units
- Philips S4-1 Ultrasound TransducerZ-1625-2026 · 41 units
- Philips S5-2 Ultrasound TransducerZ-1626-2026 · 1 unit
- Philips X3-1 Ultrasound TransducerZ-1627-2026 · 17 units
- Philips X7-2 Ultrasound Transducer (this page)Z-1628-2026 · 5 units