Device product
CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in the neck area.
Z-2763-2015
Product summary
- Firm
- Med Tec Inc
- Event
- Event 71935
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18 sets
- Official record key
device-enforcement:Z-2763-2015
Official wording
Reason: The wrist straps used for positioning the patient are too long
Code information: Lot numbers M765570 and M784310.
Distribution pattern: Worldwide Distribution - US including NE, SC, and KS. Foreign distribution was made to Australia, China, Venezuela, Spain, Turkey, and Hong Kong
Derived failure modes
-
Unknown
The wrist straps used for positioning the patient are too long