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 care and in Veterinary Medicine. Material #11515088 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
UDI-DI :04056869148243 US S/N: 30001 30002 30008 30013 30029 30031 30032 30033 30034
Products Sold
UDI-DI :04056869148243 US S/N: 30001 30002 30008 30013 30029 30031 30032 30033 30034
Siemens Medical Solutions USA, Inc is recalling Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, E due to 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, t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
Siemens issued Customer Safety Advisory Notice via AX015/23/S on 6/6/23. Letter states reason for recall, health risk and action to take: Siemens will correct the hardware error via Update Instruction AX012/23/S. This measure will replace the current single tank cover of all affected systems. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026