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DRX Transportable System (2013-09-11)

Starting date:
September 11, 2013
Posting date:
October 16, 2013
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-36205

Recalled Products

DRX Transportable System 

Reason

Carestream recently received reports of a non-diagnostic image on exams when a normal exposure mode (NEM) image is taken immediately prior to an extended exposure mode (EEM) image with the system in fast preview mode. Investigation revealed that the directview version 5.5 and 5.6 console software when used with DRX-1 detector version 69 firmware contained a timing issue which could result in a non-diagnostic image.

Affected products

DRX Transportable System 

Lot or serial number
  • 107
  • 5007
Model or catalog number
  • 1021286
Companies
Manufacturer
Carestream Health Inc.
150 Verona Street
Rochester
14608
New York
UNITED STATES