Siemens Recalls Artis Angiography Systems Due to Belt Corrosion
Siemens is recalling 3,320 Artis angiography systems in the US because belt corrosion may cause system failure or unintended C-Arm movement.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (belt corrosion) that can lead to system failure and hazardous unintended movement, posing a risk of injury to patients and staff.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 3,320 Artis angiography systems distributed nationwide in the United States. The recall covers various models, including the AXIOM Artis and Artis zee series, with all serial numbers affected.
The recall is due to inappropriate cleaning that has caused unexpected corrosion of visible belts used to move system parts, such as the C-Arm. Increased corrosion may lead to belt malfunction, resulting in limited functionality or total system failure. Unintended movement of the C-Arm could create a hazardous situation for patients, operators, or staff, potentially requiring the cancellation of clinical treatment or the use of an alternative system.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the corrosion issue and ensure patient safety.
The recalled product
- Product
- Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System Material # AXIOM Artis FC 05904433…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 3,320
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Distributed nationwide across the United States.
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