Philips X3-1 Transducer Probe: Clarification on Useful Life Labeling
Philips is recalling 171,322 X3-1 Transducer Probe units nationwide to provide clarified labeling defining the ultrasound transducers' useful life.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III recall with no reported injuries, illnesses, or product defects. The issue is labeling clarification regarding product useful life, which constitutes a documentation issue.
Plain-English summary
Philips Ultrasound, Inc. is recalling the X3-1 Transducer Probe (Model 989605388101, 21715A), 171,322 units distributed nationwide in the United States.
The recall is issued to provide clarification and labeling that defines the useful life of the ultrasound transducers in the field. Healthcare facilities and professionals using these transducers should refer to the updated labeling from Philips for guidance on the product's useful life and proper maintenance.
The recalled product
- Product
- X3-1 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-deficiency
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model No. 989605388101
- 21715A
- UDI: N/A
- Serial No. 02YHPN
- 02JK1H.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03