Philips X8-2t ultrasound transducers were refurbished beyond their useful life
Philips X8-2t Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units 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: 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 X8-2t Transducer, model number 989605455171, is being recalled. The action covers 5,230 units, identified by the UDI codes in the recall notice.
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 number and UDI codes in the recall notice and follow the instructions issued by Philips Ultrasound.
The recalled product
- Product
- Philips X8-2t 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. 989605455171
- UDI: (01)00884838069718(21)B2JH74
- (01)00884838069718(21)B29746
- (01)00884838069718(21)B1ZGLZ
- (01)00884838069718(21)B34TNV
- (01)00884838069718(21)B2JJHM
- (01)00884838069718(21)B34TLN
- (01)00884838069718(21)B2C84F
- (01)00884838069718(21)B2FTXW
- (01)00884838069718(21)B24WXT
- (01)00884838069718(21)B2T8C5
- (01)00884838069718(21)B2JJGX
- (01)00884838069718(21)B2T86R
- (01)00884838069718(21)B2C8L5
- (01)00884838069718(21)B38VJZ
- (01)00884838069718(21)B2JGTC
- (01)00884838069718(21)B2VQFK
- (01)00884838069718(21)B2XD5P
- (01)00884838069718(21)B2B8WQ
- (01)00884838069718(21)B2JGNL
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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