Q-Rad System (2019-03-30)
- Starting date:
- March 30, 2019
- Posting date:
- April 5, 2019
- 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-69476
Last updated:
Affected Products
Q-Rad System
Reason
Carestream Health has discovered a potential safety problem that could lead to the breakage of the two steel cables that attach the equipment to its ceiling support mechanism. It has been determined that in some instances when the main steel rope breaks, the safety lock may not be triggered and the safety rope is then providing the only support for the lifting column and support arm. This safety rope is not designed for continuous load and on-going movement of the support arm leading to potential serious injury for users and patients, should the safety rope also fail.
Affected products
Q-Rad System
Lot or serial number
- RS590LD SN Range RS590LD12K-1002 to RS590LD14N-1005.
- RS580 SN Range 1039 to 5149.
Model or catalog number
More than 100 numbers, contact manufacturer.
Companies
- Manufacturer
- Carestream Health, Inc.
150 Verona Street
Rochester
14608
New York
UNITED STATES
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