Philips C5-2 Lumify Transducer Probe labeling clarification on useful life
Philips issues labeling clarification for the C5-2 Lumify Transducer Probe to define useful life of ultrasound transducers. The recall affects approximately 171,322 units distributed nationwide in the US.
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 device with labeling clarification only. No hazards, illnesses, injuries, or device failures reported. The issue is informational—providing clarification on useful life definition, not a safety defect.
Plain-English summary
Philips Ultrasound, Inc. is issuing a labeling clarification for the C5-2 Lumify Transducer Probe (Model Nos. 989605450353, 989605450352, 989605477131, and others). The recall affects approximately 171,322 units that were distributed nationwide in the United States.
The FDA-classified Class III recall addresses the need to provide clarification and labeling to define the useful life of ultrasound transducers in the field. This is a labeling and documentation matter, not a report of patient harm or device malfunction.
Healthcare providers and facilities using this transducer probe should contact Philips for updated labeling information regarding the device's useful life as specified in this recall.
The recalled product
- Product
- C5-2 Lumify Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-clarification
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 (20)
- Model No. 989605450353
- 989605450352
- 989605477131
- 989605450351
- 989605451181
- 989605427371
- UDI: 010088483808517621F0FYRG
- (01)00884838085176(21)B3H57K
- (01)00884838068766(21)B1W1CR
- (01)00884838086555(21)B2C7Z5
- (01)00884838085176(21)F07VCW
- (01)00884838085176(21)F0J0P8
- (01)00884838061828(21)B1MBZM
- (01)00884838068766(21)B1W1NG
- (01)00884838085176(21)B1MC3H
- (01)00884838085176(21)B1QHPM
- (01)00884838085176(21)B1W13D
- (01)00884838085176(21)B1W153
- (01)00884838085176(21)B27BC5
- (01)00884838085176(21)B3PH0F
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03
- HighPhilips Allura Imaging Systems Hard Drive Degradation Affects Functionality
FDA (Devices) · 2026-06-03
- ModerateMedtronic Deep Brain Stimulation Pocket Adaptor Kits recalled for incorrect expiration dates
FDA (Devices) · 2026-06-03
- SevereMedline spinal injection kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03