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Terminated

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

FDA Recall Z-0624-2011 · Posted 2010-12-16

Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeFQO
Date Initiated2010-08-12
Date Terminated2012-09-27
Product Quantity1,635 tables

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.

Firm Action

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

Distribution Pattern

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, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV, and in the countries of Australia, Canada, China, Columbia, Dominican Republic, India, Israel, Mexico, New Zealand, Saudi Arabia, Singapore, South Korea and Taiwan.

Official Source

View FDA Recall →

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

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