Philips C9-5ec Transducer Probe Recalled for Labeling Clarification on Useful Life
Philips Ultrasound is recalling the C9-5ec Transducer Probe due to a labeling clarification need regarding the device's useful life. Approximately 171,322 units distributed nationwide 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 a Class III FDA recall with no reported illnesses or injuries. The recall addresses labeling clarification regarding device useful life, which is a documentation matter rather than an explicit safety hazard.
Plain-English summary
Philips Ultrasound, Inc. is recalling the C9-5ec Transducer Probe, an ultrasound transducer device. Approximately 171,322 units were distributed nationwide.
The FDA issued this Class III recall to provide clarification and labeling intended to better define the useful life of ultrasound transducers in clinical use.
Users of the C9-5ec Transducer Probe should review any updated information provided by Philips Ultrasound regarding the device's useful life. Questions about the recall or updated labeling should be directed to Philips Ultrasound.
The recalled product
- Product
- C9-5ec Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-defect
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. 989605387351
- 989605440802
- UDI: (01)00884838067677(21)B1X88J
- (01)00884838067677(21)B264HW
- (01)00884838067677(21)B36JG7
- (01)00884838067677(21)B29HQQ
- (01)00884838067677(21)B264LH
- (01)00884838067677(21)B2X78L
- (01)00884838067677(21)B3055N
- (01)00884838067677(21)B284J2
- (01)00884838067677(21)F06LP2
- (01)00884838067677(21)B1K3BP
- (01)00884838067677(21)B32262
- (01)00884838067677(21)B36JHC
- (01)00884838067677(21)B2J631
- (01)00884838067677(21)B3224T
- (01)00884838067677(21)F02K00
- (01)00884838067677(21)B2X710
- (01)00884838067677(21)B3MDX4
- (01)00884838067677(21)B1LJYQ
Distribution
Distributed nationwide across the United States.
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