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MEERA ST mobile operating table recallZ-0460-2025 · Getinge Usa Sales Inc · initiated Oct 3, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Getinge Usa Sales Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Component design/selection

What the company is doing

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 [email protected] or by faxing the form to (800) 976-2664. Actions to be taken by Getinge: Maquet/Getinge ha

Recall details

Recall number
Z-0460-2025
Status
Open, Classified
Initiated by the company
Oct 3, 2024
Posted by the FDA
Nov 14, 2024
Recalling firm
Getinge Usa Sales Inc
Quantity
112 units
Product code
FQO
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.

Product description

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: 710001B0

Code information (models, lots, serial numbers)

UDI-DI: 04046768136298 S/N: 680 through 707

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 95498).

Sources and updates

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