Terminated

Cmax 110v Surgical Table Hand Control. The Cmax Surgical Table is a mobile, electro-hydraulically operated surgical table designed to support all general surgical procedures, with the addition of STERIS table accessories. Tabletop positioning and articulations are controlled via the hand control.

FDA Recall Z-1599-2009 · Posted 2009-07-21

Recalling FirmSteris Corp

Recall StatusTerminated

Product CodeFQO

Date Initiated2009-05-12

Date Terminated2013-02-26

Product Quantity217 Units

Reason for Recall

A limited quantity of the Cmax Hand Controls, P150832-500, were manufactured without Loctite thread locker on the screws that attach the mounting clip to the hand control case. This clip provides a means of storing the hand control on the table side rails. It is possible that screws without Loctite can work loose and the clip can become separated from the hand control. If both screws back out c

Firm Action

Steris Corp. issued an "Urgent Product Correction" notice dated May 12, 2009 informing consignees of the affected device and that a Steris Service Representative with be in contact to make the necessary inspection and repairs to the device. Steris Field Service Dispatch can be reached at 1-800-288-2805. For further questions, contact Steris at 1-800-548-4873 extension 27318.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution -- U.S. states of AL, AR, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WI and WV and countries of Canada and Taiwan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.