Device product
Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85
Z-1503-2014
Product summary
- Event
- Event 67859
- Status
- Terminated
- Classification
- Class II
- Quantity
- 985 devices
- Official record key
device-enforcement:Z-1503-2014
Official wording
Reason: The footboard of Patient support for stitching can be fixed in upper position. When the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held.
Code information: Units distributed from November 2006 through March 2014.
Distribution pattern: Nationwide: US: AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, WY / Worldwide including Canada & Mexico
Derived failure modes
-
Unknown
The footboard of Patient support for stitching can be fixed in upper position. When the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held.