FDA Medical Device Recalls (openFDA)
Maquet Inc.: Magnus Hybrid operating table columns 1180.01A1 and 1180.01B1
- Recall number
- Z-0389-2012
- Recalling firm
- Maquet Inc.
- Product
- Magnus Hybrid operating table columns 1180.01A1 and 1180.01B1
- Status
- Terminated
- Initiated
- 2011-09-19
- Posted
- 2012-01-11
- Terminated
- 2011-12-08
- Reason
- A component of the Magnus hybrid OR system fails to respond to a position command.
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LFQO
- Firm FEI
- 3008355164
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28