Cios Select VA 21 with FD- A Mobile X-ray system recall
Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics…
Why was Cios Select VA 21 with FD- A Mobile X-ray system 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).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI :04056869148243 US S/N: 30001 30002 30008 30013 30029 30031 30032 30033 30034
- Product
- Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 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.
- Recall date
- August 2, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)