Philips Ultrasound C10-4ec Transducer Probes Recall for Useful Life Labeling Clarification
Philips is recalling C10-4ec ultrasound transducer probes nationwide to provide clarification and labeling regarding the useful life of these devices. 171,322 units are affected.
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 issued for clarification and labeling regarding device useful life. Per the severity rubric, documentation and labeling issues without reported hazards or injuries constitute Low severity.
Plain-English summary
Philips Ultrasound, Inc is recalling C10-4ec transducer probes. The recall affects 171,322 units distributed nationwide in the United States. Affected model numbers include 989605413712, 989605438601, and 989605391092, with multiple associated serial number batches.
The recall is issued to provide clarification and labeling to define the useful life of these ultrasound transducers in the field. The manufacturer is addressing clear communication regarding device useful life.
This recall has been classified as FDA Class III.
The recalled product
- Product
- C10-4ec 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. 989605413712
- 989605438601
- 989605391092
- UDI: (01)00884838061507(21)B2KPHY
- (01)00884838067837(21)B1JT51
- (01)00884838067837(21)B1JTFN
- (01)00884838067837(21)B1JTJY
- (01)00884838067837(21)B1MT19
- (01)00884838067837(21)B1MT9L
- (01)00884838067837(21)B1MT9X
- (01)00884838067837(21)B1MT9Y
- (01)00884838067837(21)B1MTDR
- (01)00884838067837(21)B1MTDX
- (01)00884838067837(21)B1MTDZ
- (01)00884838067837(21)B1MTY9
- (01)00884838067837(21)B1N32V
- (01)00884838067837(21)B1N33Y
- (01)00884838067837(21)B1N340
- (01)00884838067837(21)B1N34V
- (01)00884838067837(21)B1N352
Distribution
Distributed nationwide across the United States.
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