Z-0239-2023Class II

Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN

Name: Z-0239-2023 Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
Creator: Getinge Usa Sales Inc
Published: 2022-10-14
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2022-10-14 / Open, Classified / root cause: manufacturing process

FDA source

Getinge Usa Sales Inc began a recall of Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN on 2022-10-14. FDA classified it as Class II and gives the reason as "The back rest may unintentionally drop suddenly, resulting in adverse health consequences if a patient were to fall on the floor head first and at a steep angle". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0239-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-14
Posted: 2022-11-15
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
Product code: FQO Table, Operating-Room, Ac-Powered
Reason for recall: The back rest may unintentionally drop suddenly, resulting in adverse health consequences if a patient were to fall on the floor head first and at a steep angle.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: On October 14, 2022, the firm notified affected customers through Urgent Medical Device Correction letters. Customers were provided with extra precautions to take in order to continue use of the device. If you have any questions, please contact your Getinge representative or call the Getinge Customer Support at (888) 943-8872 (select option 2), Monday through Friday, 8AM - 6PM ET.
Quantity in commerce: 5 US; 1008 OUS
Distribution: Worldwide - US Nationwide distribution in the states of MA, NJ, SC, and TN. The countries of Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Bulgaria (BG), Canada (CA), China (CN), Croatia (HR), Czech Republic (CZ), Denmark (DK), Estonia (EE), Finland (FI), France (FR), Germany (DE), Greece (GR), Hungary (HU), Indonesia (ID), Israel (IL), Italy (IT), Japan (JP), Jordan (JO), Kuwait (KW), Lithuania (LT), Luxembourg (LU), Mexico (MX), Montenegro (ME), Morocco (MA), Netherlands (NL), Norway (NO), Pakistan (PK), Peru (PE), Poland (PL), Portugal (PT), Romania (RO), Russia (RU), Saudi Arabia (SA), Slovenia (SI), South Korea (KR), Spain (ES), Sweden (SE), Switzerland (CH), Taiwan (TW), Thailand (TH), Tunisia (TN), Turkey (TR), United Arab Emirates (AE), United Kingdom (GB), Yemen (YE).
Product codes and lots: No UDI - product discontinued in 2008. Part Number 1140.20F0: Serial Nos. 3, 8, 9, 10 Part Number 1140,20AN: Serial No. 851

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0239-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0239-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)