Recall record at a glance
| Official record | Z-0523-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Report date | Dec 20, 2023 |
| Recall initiation date | Oct 17, 2023 |
| Quantity | 38 worldwide, 11 US |
| Location | Malvern, PA, United States |
Official product description
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Why the product was recalled
Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.
Distribution information
US Nationwide - Worldwide Distribution: Domestic distribution to FL GA IA IL IN MI MN MO MT PA TX. Foreign distribution to Australia Canada Switzerland China Germany Denmark Egypt Spain Finland United Kingdom Israel Netherlands Sweden South Africa
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
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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