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: 720001B0
- Company
- Getinge Usa Sales Inc
- Recall Initiated
- October 3, 2024
- Posted
- November 14, 2024
- Recall Number
- Z-0456-2025
- Quantity
- 342 units
- Firm Location
- Wayne, NJ
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
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.
Lot / Code Info
UDI-DI: 04046768124332 S/N: 11399 through 11746
Root Cause
Component design/selection
Action Taken
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