The Recall Desk
HighFDA (Devices)·Z-1488-2013·Announced 2013-06-12

Berchtold Recalls Hand Controls for Operon Surgical Tables

Berchtold Corp. is recalling 3,763 hand controls for Operon surgical tables due to reports of unintended movements.

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 involves a medical device with a functional defect (unintended movements) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Berchtold Corp. is recalling 3,763 hand controls used to operate Operon D750, D752, D760, D820, and D850 surgical tables. The recall was initiated after the firm received complaints regarding unintended movements of the equipment.

The affected hand controls were distributed nationwide. The devices are neither serialized nor lot coded. The recall is classified as Class II by the U.S. Food and Drug Administration.

Healthcare facilities should stop using the affected hand controls and contact Berchtold Corp. for instructions on the next steps.

The recalled product

Product
Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables
Manufacturer
Berchtold Corp.
Category
Medical Device — Surgical Table Accessories
Hazard
Affected units
3,763

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 (1)

  • The hand controls are neither serialized nor lot coded.

Distribution

Distributed nationwide across the United States.

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