Recall record at a glance
| Official record | Z-1469-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Report date | May 3, 2023 |
| Recall initiation date | Mar 21, 2023 |
| Quantity | 4 units US |
| Location | Malvern, PA, United States |
Official product description
ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600
Why the product was recalled
Examination room monitor connected with the hybrid cable may have a display issue and no image function is available
Distribution information
Worldwide - US Nationwide distribution in the states of FL, SD, PR and the countries of Angola, Argentina, Australia, Brazil, Bulgaria, China, Georgia, Germany, India, Indonesia, Iraq, Japan, Malaysia, Morocco, Nepal, Nigeria, Poland, Russia, Rwanda, Serbia, Slovenia, South Africa, Spain, Sudan, Syria, Taiwan, Thailand, Uganda, Ukraine, United Kingdom, Uzbekistan, Vietnam.
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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