Cios Select recallZ-2240-2023 · Siemens Medical Solutions USA, Inc · initiated Jun 5, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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).
FDA root cause category: Nonconforming Material/Component
What the company is doing
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
Recall details
- Recall number
- Z-2240-2023
- Status
- Open, Classified
- Initiated by the company
- Jun 5, 2023
- Posted by the FDA
- Jul 27, 2023
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 9 units
- Product code
- OWB
- FDA submissions
- K210309
- 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 description
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
Code information (models, lots, serial numbers)
UDI-DI :04056869148243 US S/N: 30001 30002 30008 30013 30029 30031 30032 30033 30034
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Cios Select 11020806Siemens Shanghai Medical Equipment Ltd. · Interventional fluoroscopic x-ray system1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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