Z-1734-2019Class II

GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0...

Name: Z-1734-2019 GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0...
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2019-05-06
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2019-05-06 / Terminated / root cause: manufacturing process

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 710001B0 (7) Part... on 2019-05-06. FDA classified it as Class II and gives the reason as "User may suffer an electric shock when coming in contact with the exposed electronic components". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1734-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-06
Posted: 2019-06-04
Terminated: 2022-07-06
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 710001B0 (7) Part 710001F0 Product Usage: The Meera Mobile Operating Table is designed to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment.
Product code: LGX Table, Examination, Medical, Powered
Reason for recall: User may suffer an electric shock when coming in contact with the exposed electronic components
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Maquet /Getinge issued URGENT MEDICAL DEVICE CORRECTION Notice on 5/6/19, identified issued, health risk and action to take: Per the IFU, section 8.1, a visual and functional check is required to be performed by a trained person before operation; If the plastic socket of the cold-device plug is pulled out do not try to put it back into the housing and if there are any exposed electronic components: do not touch them. Call your in-house technical service and arrange the repair of the table. Per IFU section 8.5 a defective product may not be used and may not be repaired by yourself. Complete/sign and return the MEDICAL DEVICE RECALL CORRECTION RESPONSE FORM. Questions contact Technical Support Department at 1-888-627-8383 (press option 3 then option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. Expanded Recall: Maquet/Getinge issued letters on 9/24/20 to consignees via FedEx 2 day Delivery with Signature Proof of Delivery (SPOD).
Quantity in commerce: U.S: 163; Foreign: 1864. Expanded: US:27 Foreign: 455
Distribution: Worldwide - US Nationwide Distribution Foreign: ALGERIA ANGOLA ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BOLIVIA BOTSWANA BOSNIA AND HERZEGOVINA BRAZIL BULGARIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA CZECH REPUBLIC DENMARK ECUADOR EGYPT FINLAND FRANCE GABON GERMANY GREECE HONG KONG HONDURAS HUNGARY ICELAND INDIA IRAN IRELAND ISRAEL ITALY JAPAN JORDAN KUWAIT LATVIA LEBANON LITHUANIA MACEDONIA MALAYSIA MAURITIUS MEXICO MOLDAVA MONTENEGRO MOROCCO MYANMAR NETHERLANDS NAMIBIA NORWAY NEW ZEALAND PAKISTAN PARAGUAY PERU PHILIPPINES POLAND PORTUGAL ROMANIA SAUDI ARABIA SERBIA SINGAPORE SLOVAKIA SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND SYRIA TAIWAN TANZANIA THAILAND TURKEY TURKMENISTAN UKRAINE UNITED ARAB EMIRATES URUGUAY UNITED KINGDOM VIETNAM
Product codes and lots: (1) Part 720001B2 S/N 1 to S/N 416 (2) Part 720001B0 S/N 1 to S/N 1416 (3) Part 720001F2 S/N 1 to S/N 91 (4) Part 720001F0 S/N 1 to S/N 220 (5) Part 710001B2 S/N 1 to S/N 8 (6) Part 710001B0 S//N 1 to S/N 11 (7) Part 710001F0 S/N 1 Expanded lots: 720001B2 SN 417 to SN 503 720001B0 SN 1417 to SN 1689 720001F2 SN 92 to SN 119 720001F0 SN 221 to SN 226 and SN 701 to 711 710001B2 SN 9 to SN 14 710001B0 SN 12 to SN 88

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1734-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1734-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-04

Product code LGX

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)