Philips S7-2 Ultrasound Transducers Recalled: Refurbished Beyond Useful Life
Philips Ultrasound is recalling 5,230 S7-2 transducers that were refurbished beyond their useful life. The devices were distributed nationwide and internationally and may not function reliably.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II medical device recall involves ultrasound transducers refurbished beyond their useful life, creating a risk of device malfunction or failure. No injuries or illnesses have been reported, placing this in the risk-of-harm category without reported harm.
Plain-English summary
Philips Ultrasound, Inc. is recalling 5,230 S7-2 Transducer units. According to the FDA, these ultrasound transducer devices were refurbished beyond their useful life.
The devices were distributed nationwide within the United States and internationally to numerous countries including Australia, Austria, Belgium, Brazil, Canada, Chile, China, France, Germany, India, Israel, Italy, Japan, South Korea, Mexico, Singapore, Spain, Switzerland, Taiwan, Turkey, United Kingdom, and others.
The specific models included in the recall are 989605440772, 989605440771, and 989803002261. Healthcare facilities and providers should consult the FDA recall notice and contact Philips Ultrasound, Inc. for further information and guidance.
The recalled product
- Product
- Philips S7-2 Transducer.
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- device-degradation
- equipment-malfunction
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. 989605440772
- 989605440771
- 989803002261
- UDI: (01)00884838067646(21)032MLP
- (01)00884838067646(21)B1MMJ8
- (01)00884838067646(21)02M708
- (01)00884838067646(21)02Q7XJ
- (01)00884838067646(21)03CX7R
- (01)00884838067646(21)031FV7
- (01)00884838067646(21)03C7PW
- (01)00884838067646(21)02MJXP
- (01)00884838067646(21)02MD57
- (01)00884838067646(21)B07FCJ
- (01)00884838067646(21)037HLQ
- (01)00884838067646(21)B0D3FH
- (01)00884838067646(21)031CCH
- (01)00884838067646(21)B0M2ZJ
- (01)00884838067646(21)039TX5
- (01)00884838067646(21)02P5NP
- (01)00884838067646(21)031KD1
Distribution
Distributed nationwide across the United States.
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