Health product recall

DRX-Revolution Mobile X-Ray System

Last updated

Summary

Product
DRX-Revolution Mobile X-Ray System
Issue
Medical devices - Performance issue
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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