Philips Ultrasound Recalls L17-5 Transducer Probes for Labeling Clarification
Philips Ultrasound recalls 171,322 L17-5 Transducer Probes to provide clarification on their useful life. This Class III recall affects devices distributed nationwide.
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 focused on labeling clarification regarding useful life; no injuries or illnesses reported. The issue is documentation-related.
Plain-English summary
Philips Ultrasound, Inc. is recalling 171,322 L17-5 Transducer Probes that were distributed nationwide in the United States.
The recall has been issued to provide clarification and updated labeling regarding the useful life of these ultrasound transducers.
Healthcare facilities and medical professionals using these devices should contact Philips Ultrasound, Inc. for guidance on the defined useful life of their devices.
The recalled product
- Product
- L17-5 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-deficiency
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. 8500-1662-01
- 989605366373
- 989605388061
- 989605366371
- UDI: (01)00884838064614(21)B20XYG
- (01)00884838064614(21)B2HK04
- (01)00884838064614(21)B36C77
- (01)00884838064614(21)B22N5X
- (01)00884838064614(21)B1YQ5T
- (01)00884838064614(21)B30M34
- (01)00884838064614(21)B3GX1Q
- (01)00884838064614(21)B3H0X1
- (01)00884838064614(21)B3P6N2
- (01)00884838064614(21)B22N0X
- (01)00884838064614(21)B2YF79
- (01)00884838064614(21)B1XRFM
- (01)00884838064614(21)B2YD0X
- (01)00884838064614(21)B3BZNW
- (01)00884838064614(21)B2YNKW
- (01)00884838064614(21)B1QBQ1
Distribution
Distributed nationwide across the United States.
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