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Open, Classified

Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.

FDA Recall Z-2420-2025 · Posted 2025-08-22

Recalling FirmMAQUET GMBH
Recall StatusOpen, Classified
Product CodeFQO
Date Initiated2025-07-14
Product Quantity315 units (8 US, 307 OUS)

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.

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]

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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