Z-0462-2025Class II

MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately...

Name: Z-0462-2025 MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately...
Creator: Getinge Usa Sales Inc
Published: 2024-10-03
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2024-10-03 / Open, Classified / root cause: design

FDA source

Getinge Usa Sales Inc began a recall of MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as... on 2024-10-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0462-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-03
Posted: 2024-11-14
Recalling firm: Maquet Cardiovascular Us Sales, LLC
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: 700001B0
Product code: FQO Table, Operating-Room, Ac-Powered
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
Root cause tag: design
FDA root 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 [email protected] or by faxing the form to (800) 976-2664. Actions to be taken by Getinge: Maquet/Getinge ha
Quantity in commerce: 112 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.
Product codes and lots: UDI-DI: 04046768136786 S/N: 491 - 603

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0462-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0456-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-14
Z-0457-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-14
Z-0458-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-14
Z-0459-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-14
Z-0460-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-14
Z-0461-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-14
Z-0462-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-14
Z-0463-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-14

Product code FQO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)