Device product

OT1000 Series Orthopedic Surgical Tables

Z-2248-2016

May 23, 2016

Class II

Product summary

Firm: Steris Corporation
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
reason.no_named_rule · v1.0.0

STERIS has identified that the pivot pin assembly located on the table top may become loose preventing the table from articulating properly.