X-ray therapy applicator base plates may detach from device body
Xstrahl Limited is recalling treatment applicators for Gulmay Medical 150 and Xstrahl 150 X-ray therapy systems. The base plate may detach from the applicator body, potentially affecting treatment positioning and delivery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device used in radiotherapy with a mechanical failure risk. No illnesses or injuries have been reported, but the device is designed for therapeutic use where a detached base plate could compromise treatment positioning, fitting the High severity category for risk-of-harm products without reported injury.
Plain-English summary
Xstrahl Limited is recalling 120 treatment applicators used with Gulmay Medical 150 and Xstrahl 150 superficial X-ray therapy systems. The affected applicators are identified by product codes GM0072, GM0077, GM0086, GM0117, GM0131, GM0158, GM0184, GM0189, GM0275, GM0307, GM0338, GM0379, GM0414, GM0469, and GM0506.
The base plate of the treatment applicator may detach from the main body of the device. This could affect the proper positioning and function of the applicator during use.
The recalled applicators were distributed to the United States and to multiple international locations including Canada, Mexico, Australia, UK, and others. The FDA classified this as a Class II recall.
The recalled product
- Product
- Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
- Manufacturer
- Xstrahl Limited
- Hazard
- device-detachment
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 (15)
- GM0072
- GM0077
- GM0086
- GM0117
- GM0131
- GM0158
- GM0184
- GM0189
- GM0275
- GM0307
- GM0338
- GM0379
- GM0414
- GM0469
- GM0506
Distribution
Distribution scope not specified by the agency.
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