Device product
OT1000 Series Orthopedic Surgical Tables
Z-2248-2016
Product summary
- Event
- Event 74264
- Status
- Terminated
- Classification
- Class II
- Quantity
- 148
- Official record key
device-enforcement:Z-2248-2016
Official wording
Reason: STERIS has identified that the pivot pin assembly located on the table top may become loose preventing the table from articulating properly.
Code information: OT1000, OT1100, and OT1200 Orthopedic Surgical Table
Distribution pattern: AL;AK, AZ; AR; CA; CO; CT; DC; FL; GA; IL; IN; IA; NY; NJ; NC; OH; OK; OR; PA; PR; SC; TX; UT and VA. Foreign accounts: Canada; France; Korea; Panama; Qatar and Thailand.
Derived failure modes
-
Unknown
STERIS has identified that the pivot pin assembly located on the table top may become loose preventing the table from articulating properly.