Recall Z-2168-2013 ยท GDC Table, Operating-Room, Electrical
Berchtold Corp.
OPERON D850 Surgical Table Product Usage: Surgical Table
| Date | Sep 9, 2013 (initiated Apr 16, 2012) |
| Status | Terminated |
| Reason | Table was not lowering. |
| Root cause | Nonconforming Material/Component |
| Action | Berchtold sent a Customer Notification letter dated April 16, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that BERCHTOLD will upgrade the OPERON Surgical tables with a new firmware version that will eliminate the potential for experiencing problems. For questions call 843-569-6100 ext. 322. |
| Quantity | 263 |
| Distribution | USA Nationwide Distribution in the states of AL, AZ, CA, CO, CT, FL, GA, HI.IL, IA, KY, LA, MD, MA, MI, MN, MS, NH, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WI and including Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.