Z-1488-2013Class II

Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON...

Name: Z-1488-2013 Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON...
Creator: Berchtold Corp.
Published: 2013-03-12
License: https://open.fda.gov/license/

Berchtold Corp. / initiated 2013-03-12 / Terminated / root cause: design

FDA source

Berchtold Corp. began a recall of Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables on 2013-03-12. FDA classified it as Class II and gives the reason as "The firm received complaints for unintended movements". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1488-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-12
Posted: 2013-06-06
Terminated: 2017-05-08
Recalling firm: Berchtold Corp.
Product: Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables
Product code: GDC Table, Operating-Room, Electrical
Reason for recall: The firm received complaints for unintended movements.
Root cause tag: design
FDA root cause: Device Design
Action: Berchtold sent an Urgent Medical Device Recall letter in March 2013, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were recommended to clean the affected product and use the instructions to reduce the possibility of unintended movements until the firm could replace the affected product. Customers with questions were advised to contact the Berchtold Operon Pendanct Recall Coordinator at 800-243-5135, or 843-569-6100, ext 306. For questions regarding this recall call 843-569-6133.
Quantity in commerce: 3763
Distribution: Nationwide Distribution
Product codes and lots: The hand controls are neither serialized nor lot coded.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1488-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1488-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06

Product code GDC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)