Philips 3D6-2 Ultrasound Transducer Probe labeling clarification for useful life
Philips Ultrasound is clarifying labeling on 171,322 3D6-2 Transducer Probes to better define the useful life of these ultrasound devices. This Class III recall affects units distributed nationwide.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall focused on labeling clarification regarding device useful life. No injuries, illnesses, or deaths are reported. Class III recalls are typically scored 1 or 2; this purely informational labeling update with no reported hazard qualifies as Low severity.
Plain-English summary
Philips Ultrasound, Inc. has issued a recall of approximately 171,322 units of the 3D6-2 Transducer Probe, an ultrasound medical device.
The recall is being issued to provide clarification and labeling updates that define the useful life of ultrasound transducers in clinical use. This ensures healthcare providers have accurate information about device lifespan and performance expectations.
The affected transducers were distributed nationwide in the United States. The recall affects units with model number 989605440872 and serial numbers including 031XK6, 02VF0G, 02M3N3, 031VQT, 03GKDF, 02TWD3, 02NDCL, 02CBD4, and 02KWQ9.
Healthcare facilities using these devices should consult the updated labeling from Philips Ultrasound for information about proper device useful life and any necessary follow-up actions.
The recalled product
- Product
- 3D6-2 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- inadequate-labeling
- device-lifespan
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 (12)
- Model No. 989605440872
- 8500-2032-01
- UDI: N/A
- Serial No. 031XK6
- 02VF0G
- 02M3N3
- 031VQT
- 03GKDF
- 02TWD3
- 02NDCL
- 02CBD4
- 02KWQ9.
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