The Recall Desk

FDA (Devices) recall action 86495

Maquet Cardiovascular Us Sales, Llc recalled 2 products on 2020-10-28

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-10-28
Critical
0
Units
68

Why these products were recalled

Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and electronic parts exposed; where the socket was pulled out and main cable is still connected to the main socket (power source), there is a risk that a user or third person may suffer an electric shock when coming in contact with the exposed electronic components

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2020-10-28

    Maquet Yuno II Mobile Operating Table Recalled for Electric Shock Risk

    Maquet is recalling Yuno II Mobile Operating Tables because a plastic socket may pull out, exposing electronic parts and creating an electric shock hazard.

    Product
    Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143302F0 (US) Part 143302B0 (OUS)
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-10-28

    Maquet Yuno Mobile Operating Table Recalled for Electric Shock Risk

    Maquet is recalling Yuno Mobile Operating Tables because a plastic socket may pull out, exposing electronic parts and creating an electric shock hazard.

    Product
    Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143301F0 (US) Part 143301B0 (OUS)
    Category
    Distribution
    0 states