X7-2t Ultrasound Transducer Probe labeling clarification for useful life
Philips Ultrasound is issuing a labeling clarification for approximately 171,322 X7-2t transducer probes to define their useful life for clinical use.
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 involving labeling and documentation clarification. FDA Class III recalls are typically scored 1 or 2. Since no injuries, illnesses, or specific hazardous defects are reported and the issue concerns labeling clarity rather than device malfunction, this qualifies as Low severity per the rubric.
Plain-English summary
This recall involves approximately 171,322 units of the Philips X7-2t Transducer Probe distributed nationwide in the United States. The recall addresses the need to provide labeling clarification to define the useful life of these ultrasound transducers for clinical use.
The issue pertains to ensuring that healthcare providers have clear labeling information about the appropriate operational lifespan of these devices. No incidents or injuries have been reported related to this labeling clarification.
Healthcare facilities and clinics using X7-2t transducer probes should expect updated labeling from Philips Ultrasound defining the useful life of their devices. When materials are provided, users should review them to understand the specified useful life parameters and ensure appropriate device management accordingly.
The recalled product
- Product
- X7-2t Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- mis-labeling
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 (12)
- Model No. 989605414122
- 989605414122
- 989605361911
- 989605350454
- 989605461941
- 989605438611
- 989605350452
- 989605350453
- 989605455171
- 989605440772
- 989605412052
- 989605350451
Distribution
Distributed nationwide across the United States.
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