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Kodak Directview DR 7500 System and DRX-Evolution Systems (2013-12-02)
- Starting date:
- December 2, 2013
- Posting date:
- February 3, 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-37531
Recalled Products
- Kodak Directview DR 7500 System
- DRX-Evolution System / Premium OTC-FF Wallstand - No Table -1DRXGOS
- DRX-Evolution System / Premium OTC-FF Wallstand - Premium Table - 1DRXGOS
- DRX-Evolution No System with Non-Motorized OTC
- DRX-Evolution / Motorized OTC-FF Wallstand
- DRX-Evolution System with Motorization-Fixed Wall Detector / Mobile CSI Table Detector
Reason
Carestream has identified that the wall stand (WS) bucky may continue moving downward when releasing the motorized WS keypad button. The number of reported occurrences represents less than 1% of the DRX-Evolution systems installed since 2009. There have not been any reported occurrences for the DR 7500 system.
Affected products
A. Kodak Directview DR 7500 System
Lot or serial number
75000150
75000216
75000233
75000590
75000648
75000673
Model or catalog number
879 1345
Companies
- Manufacturer
-
Carestream Health Inc.
150 Verona Street
Rochester
14608
New York
UNITED STATES
B. DRX-Evolution System / Premium OTC-FF Wallstand - No Table -1DRXGOS
Lot or serial number
4208
4292
Model or catalog number
1001700
1001981
Companies
- Manufacturer
-
Carestream Health Inc.
150 Verona Street
Rochester
14608
New York
UNITED STATES
C. DRX-Evolution System / Premium OTC-FF Wallstand - Premium Table - 1DRXGOS
Lot or serial number
4031
4076
Model or catalog number
1268457
Companies
- Manufacturer
-
Carestream Health Inc.
150 Verona Street
Rochester
14608
New York
UNITED STATES
D. DRX-Evolution No System with Non-Motorized OTC
Lot or serial number
4723
Model or catalog number
1731645
Companies
- Manufacturer
-
Carestream Health Inc.
150 Verona Street
Rochester
14608
New York
UNITED STATES
E. DRX-Evolution / Motorized OTC-FF Wallstand
Lot or serial number
4199
4569
4570
4588
4670
4767
4879
Model or catalog number
1731678
8001174
8716938
Companies
- Manufacturer
-
Carestream Health Inc.
150 Verona Street
Rochester
14608
New York
UNITED STATES
F. DRX-Evolution System with Motorization-Fixed Wall Detector / Mobile CSI Table Detector
Lot or serial number
4236
4758
4828
4890
5110
Model or catalog number
1016138
8009839
Companies
- Manufacturer
-
Carestream Health Inc.
150 Verona Street
Rochester
14608
New York
UNITED STATES