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FDA (Device enforcement)Recalled 2023-06-05class ii

Siemens Medical Solutions USA, Inc: Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient

Hazard

Incorrect glue was applied on the plexiglass sheet on the single tank cover assembly could potentially fall off and the ingress of liquid may occur, the risk of electric shock exists (e.g., ingress of a large amount of liquid following the plexiglass dropping off, at the same time the user or operator happens to touch the liquid on the cover which is connected to the internal live parts).

Details from the source

Reason for recall: Incorrect glue was applied on the plexiglass sheet on the single tank cover assembly could potentially fall off and the ingress of liquid may occur, the risk of electric shock exists (e.g., ingress of a large amount of liquid following the plexiglass dropping off, at the same time the user or operator happens to touch the liquid on the cover which is connected to the internal live parts). Distribution: Worldwide - US Nationwide distribution in the states of FL, GA, KS, MN, NC, NY and the countries of Austria, Bangladesh, Brazil, Canada, China, Croatia, El Salvador, France, Germany, Indonesia, Italy, Japan, Jordan, Lebanon, Luxembourg, Mauritius, Mexico, Monaco, Peru, Philippines, Poland, Romania, Slovakia, South Africa, Spain, Switzerland, Taiwan, Ukraine, United Kingdom. Quantity: 9 units Lot/code info: UDI-DI :04056869148243 US S/N: 30001 30002 30008 30013 30029 30031 30032 30033 30034

UPC codes

04056869148243

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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