Philips L12-5 50 Transducer Probe Labeling Clarification on Useful Life
Philips is recalling 171,322 units of the L12-5 50 Transducer Probe to provide clarification and labeling regarding the product's useful life. This labeling correction affects ultrasound transducers 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 addressing a labeling issue to clarify product useful life. No illnesses, injuries, or deaths have been reported, and no immediate safety hazard is specified. FDA Class III recalls are typically scored 1 or 2; this labeling-focused recall with no reported harm warrants a score of 1.
Plain-English summary
Philips Ultrasound, Inc. is recalling 171,322 units of the L12-5 50 Transducer Probe distributed nationwide. The recall is issued to provide clarification and labeling to define the useful life of the ultrasound transducers.
No specific safety hazard or patient harm has been reported. This recall addresses the need for clearer labeling and product information regarding how long these transducers remain effective for clinical use.
Healthcare facilities and medical professionals using these transducers should refer to updated labeling and manufacturer guidance on product useful life and replacement schedules. The U.S. Food and Drug Administration classified this as a Class III recall.
The recalled product
- Product
- L12-5 50 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- product-labeling
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. 989605418552
- 989605408173
- 989605438481
- 989605420231
- 989605412401
- 989605408171
- 989605362313
- 989605396002
- 989605387311
- 989605412042
- 989605418551
- 989605409562
- 989605412072
- 989605409582
- 989605440931
- 989605361882
- 989605440932
- UDI: (01)00884838067851(21)B1N28J
- (01)00884838067851(21)B1N2GB
- (01)00884838067851(21)B20JW8
Distribution
Distributed nationwide across the United States.
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