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U.S. Department of Health and Human Services

Class 2 Device Recall Magnus 1180 Operating Table System

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 Class 2 Device Recall Magnus 1180 Operating Table Systemsee related information
Date Initiated by FirmFebruary 11, 2021
Create DateMarch 23, 2021
Recall Status1 Open3, Classified
Recall NumberZ-1296-2021
Recall Event ID 87386
Product Classification Table, operating-room, ac-powered - Product Code FQO
ProductOperating Table System
Code Information Part Number: 118001A0, 118001B0, 118001B1, 118001B2, 118001B3, 118001B4, 118001C0, 118001D0. UDI code: 04046768031500, 04046768031531, 04046768040700, 04046768088351, 04046768088061, 04046768124752, 04046768031555, 04046768031579. Serial Number: 1 3402, 1 1028, 1 1264, 1 401, 3 74, 1 81, 2 1159, 2 - 762.
FEI Number 3025504317
Recalling Firm/
Manufacturer		 Getinge Group Logistics America, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information ContactAllison Jean Kaplan
973-709-7779
Manufacturer Reason
for Recall		There is a potential for hydraulic leakage at the inclination function to occur resulting in an unintended Trendelenburg or anti-Trendelenburg movement of the table top depending on patient positioning which may lead to the patient having to be transferred to another OR table causing a delay in the procedure.
FDA Determined
Cause 2		Device Design
ActionIn February, 2021, Maquet GmbH/Getinge, will issue an Urgent Medical Device Correction notice to customers via FedEx 2 Day Delivery for the Magnus 1180 Operating Table due to a potential for hydraulic leakage to occur at the inclination function which may result in an unintended Trendelenburg or anti-Trendelenburg movement of the table top depending on patient positioning. If this were to occur, it may lead to the patient having to be transferred to another OR table causing a delay in the procedure.
Quantity in Commerce4288 units
DistributionDomestic: AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV. Foreign: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Luxembourg, Lybia, Macedonia, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Netherlands, New Caledonia, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, United Kingdom, Uzbekistan, Venezuela, Vietnam and Yemen.
Total Product Life CycleTPLC Device Report
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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