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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
- Date modified: