Recall Z-0624-2011 ยท FQO Table, Operating-Room, Ac-Powered
Steris Corporation
Cmax Surgical Tables, Model #'s: Cmax110, Cmax 220 manufactured by Steris Corporation in Montgomery, AL
| Date | Dec 16, 2010 (initiated Aug 12, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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. |
| Quantity | 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, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV, and in the countries of Australia, Canada, China, Columb |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.