Philips S7-3t ultrasound transducers were refurbished beyond their useful life
Philips S7-3t Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
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: FDA Class II recall arising from refurbishment beyond the validated service life, with no clinical consequence described in the source.
Plain-English summary
The Philips S7-3t Transducer is being recalled across the model numbers listed in the recall notice, including 989605440772, 989605440771, 989605439232 and 989605406772. The action covers 5,230 units.
The stated reason is that the ultrasound transducer devices were refurbished beyond their useful life. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Distribution was nationwide in the United States and to Australia, Austria, Belgium, Brazil and other markets. The transducers are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the model numbers and UDI codes in the recall notice and follow the instructions issued by Philips Ultrasound.
The recalled product
- Product
- Philips S7-3t 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
- 989605439232
- 989605406772
- 989605439231
- 989606708921
- 989803002661
- UDI: (01)00884838061439(21)B2103Y
- (01)00884838061439(21)B1J2M7
- (01)00884838061439(21)B2HX4N
- (01)00884838061439(21)B187KZ
- (01)00884838061439(21)B2HXHR
- (01)00884838061439(21)B2104Q
- (01)00884838061439(21)B178YZ
- (01)00884838061439(21)B22VWR
- (01)00884838061439(21)B37JGY
- (01)00884838061439(21)B131BH
- (01)00884838061439(21)B3DVFC
- (01)00884838061439(21)B1BX6R
- (01)00884838061439(21)B3JQF5
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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