Philips L12-4 Transducer Probe Recalled for Useful Life Labeling Clarification
Philips Ultrasound is recalling 171,322 L12-4 Transducer Probes distributed nationwide to provide clarification and updated labeling regarding the useful life of the ultrasound transducers.
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 involving only labeling and documentation clarification with no reported safety hazard, patient injury, or product defect. Per the rubric, documentation issues without hazard reports are classified as Low severity.
Plain-English summary
Philips Ultrasound, Inc. is recalling 171,322 L12-4 Transducer Probes that were distributed nationwide in the United States. These devices are used as part of ultrasound systems in medical settings.
The recall is being issued to provide clarification and updated labeling regarding the useful life of the ultrasound transducers in the field. The manufacturer has determined that labeling clarification is necessary to properly define the useful life of these devices.
Healthcare facilities and medical professionals using the L12-4 Transducer Probe should refer to the updated labeling from Philips Ultrasound regarding the useful life of the device. The recall affects multiple model variants identified by their respective model numbers and unique device identifiers.
The recalled product
- Product
- L12-4 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-issue
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. 989605430652
- 989605409562
- 989605427122
- 989605463401
- 989605430651
- 989605442161
- 989605418963
- 989605387852
- 989605418701
- 989605387081
- 989605412042
- 989605451171
- UDI: (01)00884838061484(21)B1X9ZR
- (01)00884838061484(21)B2Y9KT
- (01)00884838061484(21)B30VBJ
- (01)00884838061484(21)F001VD
- (01)00884838061583(21)B1XBZR
- (01)00884838061644(21)B1NM93
- (01)00884838061644(21)B1NM97
- (01)00884838061644(21)B1PKN3
Distribution
Distributed nationwide across the United States.
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