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U.S. Department of Health and Human Services

Class 2 Device Recall Corin

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 Class 2 Device Recall Corinsee related information
Date Initiated by FirmJuly 14, 2025
Date PostedAugust 22, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2420-2025
Recall Event ID 97313
Product Classification Table, operating-room, ac-powered - Product Code FQO
ProductCorin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.
Code Information Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; UDI-DI: (1) 04046768145177, (2) 04046768145184, (3) 04046768145191, (4) 04046768145207, (5) 04046768145214, (6) 04046768145221; Lot/Serial Numbers: (1) 1, 2, 3, 10, 25, 26, 27, 28, 22, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 24, (2) 9, 51, 53, 14, 15, 16, 17, 34, 35, 36, 37, 39, 40, 42, 43, 54, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 38, 44, 45, 46, 5, 13, 57, 58, 59, 18, 49, 47, 48, 7, 52, (3) 41, 5, 6, 45, 48, 49, 50, 23, 38, 10, 12, 13, 14, 84, 87, 88, 89, 7, 63, 80, 82, 83, 86, 54, 93, 94, 11, 15, 18, 20, 21, 22, 27, 28, 32, 40, 9, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 85, 55, 56, 57, 58, 59, 42, 97, 92, 17, 26, 16, 24, 25, 30, 33, 35, 36, 37, 39, 44, 53, 91, 8, 19, 90, 46, 47, 51, 52, 34, 43, 60, 62, 64, 65, 66, 67, 68, (4) 44, 70, 71, 42, 56, 65, 115, 185, 52, 105, 106, 107, 109, 145, 146, 147, 148, 11, 26, 19, 32, 33, 35, 36, 39, 53, 61, 63, 69, 14, 20, 68, 13, 18, 16, 101, 167, 170, 83, 3, 4, 23, 28, 37, 38, 40, 41, 43, 45, 47, 48, 50, 55, 58, 60, 62, 78, 81, 82, 92, 94, 96, 97, 98, 99, 100, 102, 116, 138, 139, 144, 150, 152, 153, 154, 155, 156, 165, 169, 171, 21, 22, 24, 25, 6, 17, 27, 29, 30, 34, 49, 51, 57, 64, 74, 75, 76, 77, 79, 80, 84, 85, 86, 87, 88, 89, 90, 91, 93, 95, 103, 104, 108, 110, 111, 112, 113, 114, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 140, 141, 142, 143, 172, 173, 174, 194, (5) 1, 2, 3, 4, 5, 6, 7, (6) 12, 15;
FEI Number 1841
Recalling Firm/
Manufacturer		 MAQUET GMBH
Kehler Str. 31
Rastatt Germany
For Additional Information ContactMegan Ties
888-943-8872
Manufacturer Reason
for Recall		Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from performing as intended. If the issue occurs, the operating table is unresponsive to command from both the universal remote control and override panel.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn July 21, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Customer Actions Our records indicate that you have received one or more of the serial numbers that are affected by this recall. As a result, Getinge requests that you take the following actions: 1. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred. 2. A Getinge service techinican will contact you to set up a service visit to perform the software update. 3. Complete and return the enclosed response form Getinge by e-mailing a copy to recallresponses.qrc@getinge.com. Additional Information Getinge is communicating this information to the appropriate regulatory agencies. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax using the following: " Online: www.accessdata.fda.gov/scripts/medwatch/ " Regular Mail: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form " Fax: 1-800-FDA-0178 We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact Technical Support 888-943-8872, option 4, option 2 or via email: techsupportSW.us@getinge.com
Quantity in Commerce315 units (8 US, 307 OUS)
DistributionWorldwide - US Nationwide distribution in the states of KY, NY, TX and the countries of Algeria, Australia, Austria, Bulgaria, Canada, China, Colombia, Denmark, Egypt, Estonia, Finland, France, Germany, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Lebanon, Morocco, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom.
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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