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DRX-EVOLUTION MOTORIZED WALLSTAND/DETECTOR (2015-08-04)
- Starting date:
- August 4, 2015
- Posting date:
- September 1, 2015
- 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-54856
Affected Products
- DRX-EVOLUTION/MOTORIZED OTC-FF WALLSTAND
- DRX-EVOLUTION SYS W/MOTORIZATION-FIXED WALL DETCTR/MOBILE CSI TABLE DETECTR
Reason
Carestream has identified a software defect that impacts image alignment when using the automatic stitching option for long length images. if there is no use of external fiducial markers or measurement tools (i.e. radio opaque ruler) when building a composite image and the technologist relies solely on the auto stitching software, there could be a risk of undetected stitching error that would otherwise get noticed and corrected with the use of manual stitching.
Affected products
A. DRX-EVOLUTION/MOTORIZED OTC-FF WALLSTAND
Lot or serial number
- 4076
- 4569
- 4570
- 4588
- 4670
- 4767
- 4879
- 5408
- 5442
Model or catalog number
- 1731678
- 8001174
Companies
- Manufacturer
-
Carestream Health
Inc.
150 Verona Street
New York
UNITED STATES
B. DRX-EVOLUTION SYS W/MOTORIZATION-FIXED WALL DETCTR/MOBILE CSI TABLE DETECTR
Lot or serial number
- 5266
- 5393
- 5572
- 5573
Model or catalog number
- 1010982
Companies
- Manufacturer
-
Carestream Health
Inc.
150 Verona Street
New York
UNITED STATES