Recall Register

Device recall: GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part…

Class II FDA enforcement event 82792. Recall start date: . Status in the FDA record: Terminated. Termination date: .

Reason for recall, in the words of FDA

User may suffer an electric shock when coming in contact with the exposed electronic components

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Maquet Cardiovascular Us Sales, Llc started this device recall on 6 May 2019. The firm address in the FDA record is in Wayne, NJ. FDA put the recall in Class II. FDA event 82792 has 1 product record. The first FDA enforcement report date is 12 Jun 2019. The record gives the status Terminated, with the termination date 6 Jul 2022.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Distribution

In the words of FDA.

Worldwide - US Nationwide Distribution Foreign: ALGERIA ANGOLA ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BOLIVIA BOTSWANA BOSNIA AND HERZEGOVINA BRAZIL BULGARIA CANADA CHILE CHINA…

Recalling firm

Maquet Cardiovascular Us Sales, Llc, Wayne, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 82792: product records
Recall numberProductQuantityClassStatusReport date
Z-1734-2019GETINGE 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…U.S: 163; Foreign: 1864. Expanded: US:27 Foreign: 455Class IITerminated12 Jun 2019

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2019
968
Share of these events in Class II
88%
Product records in this event
1Median of the firm: 1
Events of the firm on the register
40

Other events of the firm

Other FDA enforcement events of Maquet Cardiovascular Us Sales, Llc
InitiatedProduct (first record)TypeClassRecords
20 Nov 2020HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product UsagDeviceClass II2
30 Sep 2020Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonaDeviceClass II1
24 Sep 2020Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during anDeviceClass II2
7 Aug 2020Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump SysteDeviceClass III1
18 Jun 2020Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - ProductDeviceClass II1
20 Feb 2020Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039DeviceClass II1
10 Feb 2020Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-DeviceClass II1
16 Jan 2020Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as CentraDeviceClass III2
3 Dec 2019Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW SDeviceClass II1
11 Jul 2019Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794DeviceClass II1

Maquet Cardiovascular Us Sales, Llc: all 40 events

Official channels

Cite this page

Recall Register. FDA enforcement event 82792. https://recallregister.com/fda/ii/82792/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA device enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
Newest FDA report date on the register
23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?
The FDA record gives this distribution: Worldwide - US Nationwide Distribution Foreign: ALGERIA ANGOLA ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BOLIVIA BOTSWANA BOSNIA AND HERZEGOVINA BRAZIL BULGARIA CANADA CHILE CHINA…
What quantity of product is in FDA event 82792?
The FDA record gives this quantity: U.S: 163; Foreign: 1864. Expanded: US:27 Foreign: 455
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many device recalls of 2019 have the same class?
88% of the 968 device events that started in 2019 are in Class II.