Z-0389-2012

Magnus Hybrid operating table columns 1180.01A1 and 1180.01B1

Name: Z-0389-2012 Magnus Hybrid operating table columns 1180.01A1 and 1180.01B1
Creator: Maquet Inc.
Published: 2011-09-19
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2011-09-19 / Terminated / root cause: design

FDA source

Maquet Inc. began a recall of Magnus Hybrid operating table columns 1180.01A1 and 1180.01B1 on 2011-09-19. The reason FDA records is "A component of the Magnus hybrid OR system fails to respond to a position command". 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-0389-2012
Status: Terminated
Initiated: 2011-09-19
Posted: 2012-01-11
Terminated: 2011-12-08
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Magnus Hybrid operating table columns 1180.01A1 and 1180.01B1
Product code: LFQO
Reason for recall: A component of the Magnus hybrid OR system fails to respond to a position command.
Root cause tag: design
FDA root cause: Device Design
Action: Maquet sent a PRODUCT RECALL URGENT MEDICAL DEVICE CORRECTIVE ACTION letter dated September 19, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. To avoid the potential of a malfunction occurring prior to their scheduled Service procedure, customers were instructed to ensure that the MAGNUS table-top is positioned at the "0" pivot position and that the MAGNUS column pivot brake is secured. If it is necessary to pivot the MAGNUS table-top prior to procedure start, ensure that the column pivot brake is completely released and then completely secured when returned to "0" pivot position. Customers were instructed to ensure that all user of the affected product and other necessary persons are informed of the product correction notice. For technical support or questions call 1-888-627-8383
Quantity in commerce: 45 UNITS
Distribution: Worldwide Distribution - USA including VA, LA, MO, NC, MD, and AZ and the countries of AE, AU, CA, CH, CN, DE, DK, ES, IE, IL, SP, PL, RU, and TH.
Product codes and lots: 510 k EXEMPT 1180.01A1- Lot #0002, 0004, 0005, 0007-00011, 00013- 0017, 00019-00029, 00001 1180.01B1- lOT #00001, 00002, 00005-00012, 00014, 00015, 00017, 00018

Product code LFQO

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)