Reported Aug 2, 2023 · Ongoing
Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- 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
- Lot codes and dates
- UDI-DI04056869148243
- US S/N
300013000230008300133002930031300323003330034
- Amount recalled
- 9 units
Where it was sold
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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