Ultrasound Transducer Probe Labeling Update for Useful Life Definition
Philips is clarifying labeling on 171,322 X11-4t ultrasound transducer probes to define their useful life in clinical use. This Class III recall affects devices distributed nationwide in the US.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III device recall focused on labeling clarification regarding useful life definition. No safety hazards, adverse events, or injuries have been reported. FDA Class III recalls are typically scored 1 or 2, and this labeling clarification with no reported hazards merits a score of 1.
Plain-English summary
Philips Ultrasound, Inc has issued a Class III recall affecting 171,322 X11-4t Transducer Probes (Model No. 989605501821) with nationwide US distribution. This recall provides clarification and updated labeling to define the useful life of these ultrasound transducer probes.
The recall is classified as FDA Class III, indicating the lowest risk category. The issue involves clarifying labeling regarding the useful life definition for the device to ensure healthcare providers understand the appropriate lifespan and replacement timeline.
No adverse health effects or injuries have been reported related to this product. Facilities using X11-4t Transducer Probes should review the updated labeling from Philips regarding useful life definitions and product lifecycle guidance.
The recalled product
- Product
- X11-4t 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. 989605501821
- UDI: (01)00884838102729(21)F0JZ1H
- (01)00884838102729(21)F0KDBZ
- (01)00884838102729(21)F0KL95
- (01)00884838102729(21)F0KDC4
- (01)00884838102729(21)F0GF3C
- (01)00884838102729(21)F0JX4T
- (01)00884838102729(21)F0JW38
- (01)00884838102729(21)F0JX4N
- (01)00884838102729(21)F0JL69
- (01)00884838102729(21)F0JW3F
- (01)00884838102729(21)F0KL87
- (01)00884838102729(21)F0JTZB
- (01)00884838102729(21)F0K1V3
- (01)00884838102729(21)F0JY4F
- (01)00884838102729(21)F0K5PZ
- (01)00884838102729(21)F0KRDC
- (01)00884838102729(21)F0K5Q0
- (01)00884838102729(21)F0K5LG
- (01)00884838102729(21)F0KL8H
Distribution
Distributed nationwide across the United States.
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