Philips S4-2 Transducer Probe Labeling Clarification on Useful Life
Philips is clarifying labeling on S4-2 Transducer Probes to define product useful life. About 171,322 units distributed nationwide are affected.
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 involving labeling clarification regarding product useful life definition. No illness or injury has been reported. The recall is a documentation and labeling update to ensure clear communication of device useful life information.
Plain-English summary
Philips Ultrasound, Inc. is issuing a recall to provide clarification and labeling for the S4-2 Transducer Probe regarding the definition of the product's useful life in the field. Approximately 171,322 units have been distributed nationwide in the United States.
The recall is being issued to ensure clear labeling and definition of the ultrasound transducer's useful life. Users should reference the updated labeling provided by Philips.
For complete information about this FDA Class III recall, customers should contact Philips Ultrasound, Inc. or consult the FDA recall notice.
The recalled product
- Product
- S4-2 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-defect
- unclear-useful-life
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. 989605414692
- 989605463421
- 989605442131
- 989605387731
- 989605412042
- 989605430222
- 989605381211
- 989605430652
- 989605361982
- UDI: (01)00884838067844(21)B2TH04
- (01)00884838067844(21)B2TH20
- (01)00884838067844(21)B2TH5R
- (01)00884838067844(21)B2TH94
- (01)00884838067844(21)B2TH95
- (01)00884838067844(21)B2TRZG
- (01)04719873000067(21)F0771Y
- (01)04719873000067(21)F0K891
- 010471987300006721B24RHN
- (01)00884838067844(21)B2ZLWP
- (01)00884838067844(21)B1N04C
Distribution
Distributed nationwide across the United States.
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