OPERON D850 Surgical Table Product Usage: Surgical Table
FDA Recall Z-2168-2013 · Posted 2013-09-09
Recalling FirmBerchtold Corp.
Recall StatusTerminated
Product CodeGDC
Date Initiated2012-04-16
Date Terminated2013-09-10
Product Quantity263
Reason for Recall
Table was not lowering.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.