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Recall Observatory FDA recall evidence

Device product

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 care and in Veterinary Medicine. Material #11515088

Z-2240-2023

June 05, 2023

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 92622
Status
Ongoing
Classification
Class II
Quantity
9 units
Official record key
device-enforcement:Z-2240-2023

Official wording

Reason: 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).

Code information: UDI-DI :04056869148243 US S/N: 30001 30002 30008 30013 30029 30031 30032 30033 30034

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).