Siemens AXIOM Artis Systems Recalled for Potential Gantry Drop Risk
Siemens is recalling 37 AXIOM Artis angiography systems because a cooling unit defect may cause a system failure and gantry drop.
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 involves a structural defect in a medical device that could result in a gantry drop, posing a significant injury risk, which aligns with the 'Severe' criteria for significant injury reports or structural defects.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 37 units of the AXIOM Artis Systems. These are dedicated angiography systems used for diagnostic imaging and interventional procedures, including for pediatric and obese patients.
The recall is due to a flat detector cooling unit that uses inappropriate connectors. This defect may cause the unit to leak, leading to a system failure and a possible drop of the gantry system. The affected units were distributed nationwide in the states of WI, KY, OH, NJ, NC, FL, PA, MA, IA, TX, NY, IL, MI, AZ, CA, and LA.
Healthcare facilities should identify affected units by checking for model numbers 7412807, 7727717, or 7728392 and the specific serial numbers listed in the recall notice. Siemens is the recalling firm responsible for addressing this safety issue.
The recalled product
- Product
- AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 37
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 (4)
- Model nos. 7412807
- 7727717
- 7728392 with serial numbers: 35020
- 34999
Distribution
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