Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2420-2025Class II

Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0...

Maquet Cardiovascular Us Sales, LLC / initiated 2025-07-14 / Open, Classified

MAQUET GMBH began a recall of Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-2420-2025
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Maquet Cardiovascular Us Sales, LLC
Product
Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.
Product code
FQO Table, Operating-Room, Ac-Powered
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 root cause
Under Investigation by firm
Action
On 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 [email protected]. 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: [email protected]
Quantity in commerce
315 units (8 US, 307 OUS)
Distribution
Worldwide - 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.
Product codes and lots
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;

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2420-2025
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2420-2025Class IIOngoingVoluntary: Firm initiated