FDA Recalls Philips C9-3v Ultrasound Transducer Probe for Labeling Clarification
FDA is recalling Philips C9-3v Transducer Probes to provide clarification and labeling regarding the useful life of the devices. Approximately 171,322 units were distributed throughout the United States.
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 recall regarding labeling clarification with no reported adverse events or injuries. FDA Class III recalls typically score 1 or 2. The action addresses a documentation issue rather than an identified product safety defect, meeting the criteria for Low severity.
Plain-English summary
Philips Ultrasound, Inc. is recalling the C9-3v Transducer Probe (Model No. 989605366341) in a Class III recall. The recall is being conducted to provide clarification and labeling to better define the useful life of these ultrasound transducer devices.
The C9-3v Transducer Probe is an ultrasound transducer component used in medical imaging. Approximately 171,322 units have been distributed throughout the United States. The affected devices can be identified by Model No. 989605366341 and the UDI codes and serial numbers specified by the manufacturer.
No adverse events or injuries have been reported in connection with this device. The recall is a labeling and clarification action to address the definition of useful life for the transducers.
The recalled product
- Product
- C9-3v Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- product-labeling
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 (14)
- Model No. 989605366341
- UDI: (01)00884838024304(21)B0LBJX
- (01)00884838024304(21)B0LBXV
- Serial No. B0DCXF
- B0CT9W
- 038VLZ
- B0LBY2
- 037RDB
- B0DD3B
- B0LBJX
- B0LBXV
- 037RG6
- B0JDHK
- B0BMR8.
Distribution
Distributed nationwide across the United States.
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