Philips S7-2 Transducer Ultrasound Devices Recalled for Refurbishment
Philips Ultrasound, Inc. is recalling Philips S7-2 Transducer ultrasound devices that were refurbished beyond their useful life. The affected devices have been distributed domestically and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 II recall. The source states the devices were refurbished beyond their useful life but does not report any illnesses, injuries, or deaths. No specific harm has been documented, making this a precautionary recall.
Plain-English summary
Philips Ultrasound, Inc. is recalling Philips S7-2 Transducer ultrasound devices. The devices were refurbished beyond their useful life, which may affect their performance and safety.
Approximately 5,230 units have been distributed nationwide in the United States and to Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United Arab Emirates, Venezuela, and Vietnam.
Patients or healthcare providers who have a Philips S7-2 Transducer with one of the affected model numbers or UDI codes should contact Philips Ultrasound, Inc. for further instructions. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Philips S7-2 Transducer.
- Manufacturer
- Philips Ultrasound, Inc
- Affected units
- 5,230
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.
Part of a larger recall action
This product is one of 21 recalled by Philips Ultrasound, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 21 products in this recall →Related recalls
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