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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- 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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