Z-1296-2021Class II

Operating Table System

Name: Z-1296-2021 Operating Table System
Creator: Getinge Group Logistics America, LLC
Published: 2021-02-11
License: https://open.fda.gov/license/

Getinge Group Logistics America, LLC / initiated 2021-02-11 / Open, Classified / root cause: design

FDA source

Getinge Group Logistics America, LLC began a recall of Operating Table System on 2021-02-11. FDA classified it as Class II and gives the reason as "There is a potential for hydraulic leakage at the inclination function to occur resulting in an unintended Trendelenburg or anti-Trendelenburg movement of the table top depending on patient positioning which may lead to...". 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-1296-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-02-11
Posted: 2021-03-23
Recalling firm: Getinge Group Logistics America, LLC
Product: Operating Table System
Product code: FQO Table, Operating-Room, Ac-Powered
Reason for recall: There is a potential for hydraulic leakage at the inclination function to occur resulting in an unintended Trendelenburg or anti-Trendelenburg movement of the table top depending on patient positioning which may lead to the patient having to be transferred to another OR table causing a delay in the procedure.
Root cause tag: design
FDA root cause: Device Design
Action: In February, 2021, Maquet GmbH/Getinge, will issue an Urgent Medical Device Correction notice to customers via FedEx 2 Day Delivery for the Magnus 1180 Operating Table due to a potential for hydraulic leakage to occur at the inclination function which may result in an unintended Trendelenburg or anti-Trendelenburg movement of the table top depending on patient positioning. If this were to occur, it may lead to the patient having to be transferred to another OR table causing a delay in the procedure.
Quantity in commerce: 4288 units
Distribution: Domestic: AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV. Foreign: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Luxembourg, Lybia, Macedonia, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Netherlands, New Caledonia, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, United Kingdom, Uzbekistan, Venezuela, Vietnam and Yemen.
Product codes and lots: Part Number: 118001A0, 118001B0, 118001B1, 118001B2, 118001B3, 118001B4, 118001C0, 118001D0. UDI code: 04046768031500, 04046768031531, 04046768040700, 04046768088351, 04046768088061, 04046768124752, 04046768031555, 04046768031579. Serial Number: 1 3402, 1 1028, 1 1264, 1 401, 3 74, 1 81, 2 1159, 2 - 762.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1296-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1296-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-31	2021-03-23

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)