X6-1 Transducer Probe labeling clarification on useful life definition
Philips Ultrasound is issuing labeling clarification for approximately 171,322 X6-1 Transducer Probes distributed nationwide to define the useful life of these devices.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III recall involving labeling clarification on device useful life with no reported illnesses, injuries, or product defects.
Plain-English summary
Philips Ultrasound, Inc. is recalling X6-1 Transducer Probes to provide clarification and labeling regarding the useful life of these ultrasound transducers.
The recall is being issued to ensure proper labeling and clarification on the useful life of X6-1 Transducer Probes in the field.
This recall affects approximately 171,322 units of the X6-1 Transducer Probe that were distributed on a US nationwide basis. The affected models are identified by model numbers 989605409282, 989605438511, 989605357141, 989605357143, and 989605427801.
Consumers and healthcare facilities using X6-1 Transducer Probes should review the labeling clarification regarding the useful life of their devices. For additional information or questions, consumers should contact Philips Ultrasound, Inc. directly.
The recalled product
- Product
- X6-1 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-clarification
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. 989605409282
- 989605438511
- 989605357141
- 989605357143
- 989605427801
- UDI: (01)00884838061446(21)B22RP6
- (01)00884838061446(21)F01N54
- (01)00884838061446(21)B28KXP
- (01)00884838061446(21)B2HRV1
- (01)00884838061446(21)F0HR2C
- (01)00884838061446(21)B2K24P
- (01)00884838061446(21)B2L7JQ
- (01)00884838061446(21)B3D77Q
- (01)00884838061446(21)F02MHJ
- (01)00884838061446(21)B21DYX
- (01)00884838061781(21)B1Z20M
- (01)00884838061781(21)B22QTZ
- (01)00884838061781(21)B26888
- (01)00884838061781(21)B28KXF
- (01)00884838061446(21)B29X6N
Distribution
Distributed nationwide across the United States.
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