Recall record at a glance
| Official record | Z-2240-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Report date | Aug 2, 2023 |
| Recall initiation date | Jun 5, 2023 |
| Quantity | 9 units |
| Location | Malvern, PA, United States |
Official 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
Why the product 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).
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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