Class 2 Device Recall Maquet/Getinge

• Date Initiated by Firm: October 03, 2024
• Date Posted: November 14, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0458-2025
• Recall Event ID: 95498
• Product Classification: Table, operating-room, ac-powered - Product Code FQO
• Product: MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F0
• Code Information: UDI-DI: 04046768136793 S/N: 1059 through 1091
• Recalling Firm/ Manufacturer: Getinge Usa Sales Inc; 1 Geoffrey Way; Wayne NJ 07470-2035
• Manufacturer Reason for Recall: Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay
• FDA Determined Cause: Component design/selection
• Action: Maquet GmbH, a subsidiary of Getinge (Maquet/Getinge) issued Urgent Medical Device Correction (FSCA 8010652-09/25/2024-002-C) letter on 03 October 2024, via FedEx delivery. Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any of the MEERA Operating Tables with the Serial numbers listed in this notice. Note: The Product REF number (REF) and the Serial Number (SN) can be found on the product label. If the error code "50037" appears-(note below picture of the remote control displaying the Error Code), it will be displayed on the IR-Hand Control. In such cases, you can: a) Restart the IR-Hand Control by releasing the key and pressing the key again, b) Switch to the corded control device, which is unaffected by this issue, or c) Use the override control panel on the operating table. The table remains safe to use as described in the instructions for use (IFU700001XYEN05_01 / IFU710001XYEN07_01 / IFU720001XYEN14_01), with special focus on: " Chapter 7.3: Explains error messages and recovery steps. " Chapter 4.3: Details the use of the override control panel. The override control panel provides immediate access to table movements, ensuring continued operability even in the unlikely event of a remote control malfunction. Please forward this information to all current and potential MEERA Operating Tables users within your hospital / facility. " If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. " Whether or not you have affected product(s) with the Product REF numbers, please complete and sign the attached MEDICAL DEVICE CORRECTION RESPONSE FORM to acknowledge that you have received this notification. Return the completed form to Getinge by e-mailing a scanned copy to meera.tablemovement.sw@getinge.com or by faxing the form to (800) 976-2664. Actions to be taken by Getinge: Maquet/Getinge ha
• Quantity in Commerce: 22 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bhutan, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, India, Israel, Japan, Jordan, Korea, Republic Of Kuwait, "Macedonia, The Former Yugoslav Republic Of", Malaysia, Mauritius, Mexico, Montenegro, Netherlands, New Zealand, Panama, Peru, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Viet Nam.
• Total Product Life Cycle: TPLC 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.