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Health product recall

DRX Revolution Mobile X-ray System (2014-11-24)

Starting date:
November 24, 2014
Posting date:
December 11, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-42853

Recalled Products

DRX Revolution Mobile X-ray System

Reason

Carestream has identified an issue related to the DRX Revolution Mobile X-ray System where the boom arm can become loose. It has been determined that this issue is a result of an improperly assembled part which holds the X-ray tube assembly/boom to the device mounting block at the top of the column.

Affected products

DRX Revolution Mobile X-ray System

Lot or serial number

101-764

Model or catalog number

1019397

Companies
Manufacturer
Carestream Health Inc.
150 Verona Street
Rochester
14608
New York
UNITED STATES