Kodak DirectView DR 7500 System (2018-10-28)
- Starting date:
- October 28, 2018
- Posting date:
- November 15, 2018
- 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-68230
Affected products
Kodak DirectView DR 7500 System
Reason
SEDECAL S.A. notified Carestream Health Inc. of a potential safety issue that could lead to the breakage of the two steel cables that attach the equipment to its ceiling anchor. The main cause of this problem is the excessive wear of the vertical pulley where the steel cables are located. When the wear is not uniform in both grooves of the pulley, the distance between the steel cables is not constant. In the most unfavorable case, this irregular wear could cause the cables to rub against each other over time to the point of rupture.
Affected products
Kodak DirectView DR 7500 System
Lot or serial number
- S/N: 150
- S/N: 216
- S/N: 233
- S/N: 590
Model or catalog number
879 1345
Companies
- Manufacturer
-
Carestream Health, Inc.
150 Verona Street
Rochester
14608
New York
UNITED STATES