Cmax Surgical Tables, Model #'s: Cmax110, Cmax 220 manufactured by Steris Corporation in Montgomery, AL

FDA device recall Z-0624-2011 · posted 2010-12-16 · Terminated

Recall details

Recalling firm

Steris Corporation

Reason for recall

Cmax Surgical Tables may lose calibration if the table is operated only on battery power and if the table is in a low battery charge condition. This could result in the table moving into an unexpected tilt position when the Level button is depressed on the hand control keypad.

Action taken

Steris issued Urgent Field Correction Notice letters dated August 26, 2010 to each affected consignee notifying them of the voluntary field correction. A Steris Representative will contact customers to arrange for STERIS to upgrade the software in the table. For further information about this corrective action, contact Steris at 1 800 333-8828.

Root cause

Other

Status

Terminated

Product code

FQO

Quantity affected

1,635 tables

Distribution

Worldwide Distribution: USA in the following states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA,

Date initiated

2010-08-12

Date posted

2010-12-16

Date terminated

2012-09-27

Location

Mentor, OH