Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive

FDA device recall Z-2240-2023 · posted 2023-07-27 · Open, Classified

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

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).

Action taken

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

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

OWB

Quantity affected

9 units

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,

Date initiated

2023-06-05

Date posted

2023-07-27

Location

Malvern, PA

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