Cmax 110v Surgical Table Hand Control. The Cmax Surgical Table is a mobile, electro-hydraulically operated surgical tabl

FDA device recall Z-1599-2009 · posted 2009-07-21 · Terminated

Recall details

Recalling firm

Steris Corp

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

Action taken

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

Status

Terminated

Product code

FQO

Quantity affected

217 Units

Distribution

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 count

Date initiated

2009-05-12

Date posted

2009-07-21

Date terminated

2013-02-26

Location

Mentor, OH