Philips C8-5 Ultrasound Transducer Probes Useful Life Labeling Clarification
Philips Ultrasound is recalling 171,322 C8-5 Transducer Probe units nationwide to provide clarification and labeling regarding the devices' useful life.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall focused on labeling clarification regarding device useful life, with no reported illnesses or injuries. Per the severity rubric, FDA Class III recalls are typically scored 1 or 2; this labeling/documentation correction warrants a Moderate score.
Plain-English summary
Philips Ultrasound, Inc. is issuing a Class III recall of 171,322 C8-5 Transducer Probe units distributed nationwide in the United States.
The recall is being issued to provide clarification and labeling to define the useful life of the ultrasound transducers in the field.
The affected products include C8-5 Transducer Probes manufactured by Philips Ultrasound, Inc., with multiple model numbers and corresponding UDI codes as specified in the recall.
Users of affected transducer probes should contact Philips Ultrasound, Inc. for updated labeling information and clarification regarding the proper useful life of their devices.
The recalled product
- Product
- C8-5 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- mis-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 (20)
- Model No. 989605391922
- 989605438441
- 989605440822
- 989605387852
- 989605387281
- 989605391092
- 8500-1664-01
- 989605352343
- 989605352342
- UDI: (01)00884838061514(21)B1Q41K
- (01)00884838061514(21)B1QB9Z
- (01)00884838061514(21)B2859G
- (01)00884838061514(21)B2YTR3
- (01)00884838061514(21)B2YTTV
- (01)00884838061514(21)B3F4JN
- (01)00884838061514(21)F08DZC
- 010088483806151421F01W6L
- (01)00884838061514(21)F04XX6
- (01)00884838061514(21)F0FCL7
- (01)00884838061514(21)B3B4RD
Distribution
Distributed nationwide across the United States.
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