| Class 2 Device Recall Cmax Surgical Table | |
Date Initiated by Firm | August 12, 2010 |
Date Posted | December 16, 2010 |
Recall Status1 |
Terminated 3 on September 27, 2012 |
Recall Number | Z-0624-2011 |
Recall Event ID |
56659 |
Product Classification |
Table, operating-room, ac-powered - Product Code FQO
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Product | Cmax Surgical Tables, Model #'s: Cmax110, Cmax 220 manufactured by Steris Corporation in Montgomery, AL |
Code Information |
Model #'s: Cmax110, Cmax 220 |
Recalling Firm/ Manufacturer |
Steris Corporation 5960 Heisley Rd Mentor OH 44060
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For Additional Information Contact | 440-392-7601 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 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, Columbia, Dominican Republic, India, Israel, Mexico, New Zealand, Saudi Arabia, Singapore, South Korea and Taiwan. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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