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U.S. Department of Health and Human Services

Class 2 Device Recall Magnus Hybrid operating table columns

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  Class 2 Device Recall Magnus Hybrid operating table columns see related information
Date Initiated by Firm September 19, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on December 08, 2011
Recall Number Z-0389-2012
Recall Event ID 60344
Product Classification Table, operating room, ac powered - Product Code LFQO
Product Magnus Hybrid operating table columns 1180.01A1 and 1180.01B1
Code Information 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
Recalling Firm/
Manufacturer		 Maquet Inc.
45 Barbour Pond Drive
Wayne NJ 07470
For Additional Information Contact Ms. Whitney Torning
973-709-7660
Manufacturer Reason
for Recall		 A component of the Magnus hybrid OR system fails to respond to a position command.
FDA Determined
Cause 2		 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.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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