Philips C9-4v Ultrasound Transducer Probes Recalled for Useful Life Labeling Clarification
Philips Ultrasound, Inc. is recalling 171,322 C9-4v Transducer Probes nationwide. The recall provides labeling clarification regarding the useful life of these diagnostic ultrasound probes.
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 FDA Class III recall is a labeling and documentation clarification issue with no reported illnesses, injuries, or deaths. It addresses the need to define and clarify useful life through improved labeling, fitting the rubric criterion for documentation issues.
Plain-English summary
Philips Ultrasound, Inc. is recalling 171,322 C9-4v Transducer Probes (Model Numbers 989605389252, 989605418972, 989605463411, 989605442141, and others) distributed nationwide in the United States.
The FDA is managing this recall to provide clarification and labeling that defines the useful life of these ultrasound transducers. The transducers are used in diagnostic ultrasound imaging procedures in medical facilities.
Healthcare providers and clinicians nationwide using these C9-4v Transducer Probes are affected by this recall.
Customers should contact Philips Ultrasound, Inc. for clarified labeling and guidance regarding the useful life of these transducers and their proper application.
The recalled product
- Product
- C9-4v 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. 989605389252
- 989605418972
- 989605463411
- 989605442141
- 989605389251
- 989605412042
- 989605387091
- 989605418971
- UDI: (01)00884838061392(21)B1Q4CD
- (01)00884838061392(21)B1YXKM
- (01)00884838061392(21)B323T7
- (01)00884838061392(21)F00QWD
- (01)00884838061392(21)F029RH
- (01)00884838067875(21)B1N3PG
- (01)00884838067875(21)B1N3PZ
- (01)00884838067875(21)B1N3TV
- (01)00884838067875(21)B1N3W3
- (01)00884838067875(21)B1N3ZJ
- (01)00884838067875(21)B20M3Y
- (01)00884838067875(21)B27LZD
Distribution
Distributed nationwide across the United States.
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