Philips S7-2t Ultrasound Transducer Probe Recall for Useful Life Labeling
Philips is recalling approximately 171,322 S7-2t Transducer Probe units to provide labeling clarification and define the product's useful life.
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 medical device recall with no reported illnesses, injuries, or deaths. The issue is a labeling deficiency regarding useful life definition, which constitutes a documentation issue per the severity rubric.
Plain-English summary
Philips Ultrasound, Inc. is recalling the S7-2t Transducer Probe, an ultrasound medical device. Approximately 171,322 units of this product were distributed nationwide across the United States.
The recall has been initiated to provide clarification and labeling to properly define the useful life of the transducer probes when used in clinical settings.
This product is distributed to healthcare facilities and medical professionals who use ultrasound diagnostic equipment. The FDA has classified this as a Class III recall.
The recalled product
- Product
- S7-2t Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-deficiency
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. 21778A
- 989605440772
- UDI: (01)00884838067646(21)B199HC
- (01)00884838067646(21)B20ZV2
- (01)00884838067646(21)B1MMLZ
- (01)00884838067646(21)B04LQ0
- (01)00884838067646(21)B20ZW6
- (01)00884838067646(21)B0X1HK
- (01)00884838067646(21)B199CY
- (01)00884838067646(21)B02VM7
- (01)00884838067646(21)B0X1KX
- (01)00884838067646(21)B1MMLD
- (01)00884838067646(21)B20ZT7
- (01)00884838067646(21)B1MMK0
- (01)00884838067646(21)B2JGW0
- (01)00884838067646(21)B20ZVC
- (01)00884838067646(21)B199DH
- (01)00884838067646(21)B1MMJM
- (01)00884838067646(21)B1MMH3
- (01)00884838067646(21)B20ZWB
Distribution
Distributed nationwide across the United States.
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