Philips ultrasound transducer probe relabeling for clarified useful life
Philips is clarifying labeling on 171,322 ultrasound transducer probes nationwide to define the useful life of the devices. No injuries have been reported.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III device recall issued for labeling clarification only. No reported injuries, illnesses, or device malfunction. This is a precautionary relabeling measure to provide guidance on useful life, not a safety defect with reported harm.
Plain-English summary
Philips Ultrasound, Inc. has issued a Class III recall of 171,322 mC12-3 Transducer Probes distributed nationwide. The recall involves Model No. 989605495721 with multiple unique device identifiers.
The recall addresses labeling clarification regarding the useful life of the ultrasound transducer probes. Philips is providing updated labeling to better define how long these devices remain safe and effective for clinical use in the field.
Healthcare facilities using these transducers should contact Philips for clarified labeling guidance. No injuries or illnesses have been reported related to this labeling issue.
The recalled product
- Product
- mC12-3 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. 989605495721
- UDI: (01)00884838093935(21)F0FKJ7
- 010088483809393521F0FRHZ
- (01)00884838093935(21)B3XYRY
- (01)00884838093935(21)B4161X
- (01)00884838093935(21)F07K8J
- (01)00884838093935(21)F0JTY0
- (01)00884838093935(21)F04YTZ
- (01)00884838093935(21)F0550K
- (01)00884838093935(21)F094Y9
- (01)00884838093935(21)F0GJC9
- (01)00884838093935(21)B3XZRM
- (01)00884838093935(21)F0KC6Y
- (01)00884838093935(21)F0HP38
- (01)00884838093935(21)F0F164
- (01)00884838093935(21)F0KND1
- (01)00884838093935(21)F04YV6
- 010088483809393521B3Y0KC
- (01)00884838093935(21)F0JZQ6
- (01)00884838093935(21)F0JZQ7
Distribution
Distributed nationwide across the United States.
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