The Recall Desk
HighFDA (Devices)·Z-2168-2013·Announced 2013-09-18

Berchtold Corp. Recalls OPERON D850 Surgical Tables Due to Malfunction

Berchtold Corp. is recalling 263 OPERON D850 surgical tables because they were not lowering. The units were distributed nationwide in the US and Canada.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a medical device malfunction (failure to lower) that poses a risk of harm to patients, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Berchtold Corp. is recalling 263 units of the OPERON D850 Surgical Table. The recall was initiated because the tables were not lowering as intended.

The affected surgical tables were distributed nationwide in the United States, including 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, and WI, as well as in Canada.

The FDA has classified this recall as Class II. Users should contact Berchtold Corp. for further instructions regarding the recall.

The recalled product

Product
OPERON D850 Surgical Table Product Usage: Surgical Table
Manufacturer
Berchtold Corp.
Affected units
263

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 3501110-S10023
  • 3501110-S10024
  • 3501110-S10025
  • 3501110-S10205
  • 3501110-S10208
  • 3501110-S10064
  • 3501110-S10036
  • 3501110-S10043
  • 3501110-S10045
  • 3501110-S10050
  • 3501110-S10061
  • 3501110-S10062
  • 3511110-S10139
  • 3511110-S10143
  • 3511110-S10144
  • 3511110-S10162
  • 3501110-S10192
  • 3501110-S10018
  • 3511110-S10038
  • 3511110-S10041

Distribution

Distributed nationwide across the United States.

The notice also names 31 states specifically: