OPERON D850 Surgical Table Product Usage: Surgical Table

FDA device recall Z-2168-2013 · posted 2013-09-09 · Terminated

Recall details

Recalling firm

Berchtold Corp.

Reason for recall

Table was not lowering.

Action taken

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

Status

Terminated

Product code

GDC

Quantity affected

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.

Date initiated

2012-04-16

Date posted

2013-09-09

Date terminated

2013-09-10

Location

N Charleston, SC