Z-2240-2023Class II

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

Name: Z-2240-2023 Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy...
Creator: Siemens Medical Solutions USA, Inc
Published: 2023-06-05
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2023-06-05 / Open, Classified / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory... on 2023-06-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2240-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-05
Posted: 2023-07-27
Recalling firm: Siemens Medical Solutions USA, Inc.
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
Product code: OWB Interventional Fluoroscopic X-Ray System
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).
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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
Quantity in commerce: 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, Japan, Jordan, Lebanon, Luxembourg, Mauritius, Mexico, Monaco, Peru, Philippines, Poland, Romania, Slovakia, South Africa, Spain, Switzerland, Taiwan, Ukraine, United Kingdom.
Product codes and lots: UDI-DI :04056869148243 US S/N: 30001 30002 30008 30013 30029 30031 30032 30033 30034

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2240-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2240-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-27

Product code OWB

K210309Class IICios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. / cleared 2021-03-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)