Philips C8-4v Transducer Probe Recalled for Useful Life Labeling Clarification
Philips Ultrasound is recalling approximately 171,322 units of C8-4v Transducer Probes distributed nationwide to provide clarification and labeling defining the useful life of these 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 labeling clarification with no reported safety incidents, injuries, or illnesses. The recall addresses a documentation issue regarding device useful life rather than an identified safety hazard.
Plain-English summary
Philips Ultrasound, Inc. is recalling 171,322 units of C8-4v Transducer Probes distributed nationwide in the United States. The recall is being issued to provide clarification and labeling to define the useful life of ultrasound transducers in clinical field use.
The affected devices include multiple model numbers and UDI codes as identified by the FDA. Healthcare providers and facilities that use these transducer probes may be affected by this recall.
The recalled product
- Product
- C8-4v 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 (20)
- Model No. 989803002685
- 989605416131
- 989605408153
- 989605430232
- 989605416141
- 989605364943
- 989605388111
- 989605387261
- 989605408151
- 989605361973
- 989605408141
- 989605430242
- 989605364941
- UDI: Unique Device Identifier (UDI)
- (01)00884838067745(21)B1YRNV
- (01)00884838067981(21)B35BZF
- (01)00884838067981(21)B24PBY
- (01)00884838067981(21)B27T4Z
- (01)00884838067981(21)B35H6L
- (01)00884838067981(21)B1RPRM
Distribution
Distributed nationwide across the United States.
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