DRX-Revolution Mobile X-Ray System
Brand(s)
Last updated
Summary
Product
DRX-Revolution Mobile X-Ray System
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products | Lot or serial number | Model or catalog number |
---|---|---|
DRX-Revolution Mobile System | More than 10 numbers, contact manufacturer. | 8618894 |
DRX-Revolution Mobile X-Ray System | More than 10 numbers, contact manufacturer. | 8610180 1019397 |
Issue
There is a potential for unexpected failure of the electrical components within the Carestream 1.0 generator installed in your DRX-Revolution Mobile X-Ray System(s). This can lead to temporary and self-contained thermal overload within the generator. Should an event like this occur, the system will become inoperable and loud noise, burnt smell and smoke may be detectable.
Recall start date: September 20, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Health products - Medical devices - Radiology
Companies
Carestream Health, Inc.
150 Verona Street, Rochester, New York, United States, 14608
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74407
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