Siemens Artis Icono Angiography Systems Pose Electric Shock Risk
Siemens Artis icono angiography systems may pose electric shock risk if protective grounding is interrupted. Affected units sold nationwide; users should verify equipment grounding integrity.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with electrical shock hazard. No illnesses or injuries reported; the hazard is conditional and theoretical. Per the rubric, risk-of-harm products without reported injury receive a score of 3.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 13 Artis icono floor-angiography systems used for diagnostic and interventional imaging procedures due to a potential electrical shock hazard.
The hazard occurs if the protective earth (electrical ground) connection is interrupted while an additional electrical fault is present. Under these conditions, the system may fail to detect the fault current, potentially allowing electrical shock if a person contacts metallic parts of the equipment.
Affected healthcare facilities with these systems should contact the manufacturer immediately. The recalled systems were distributed nationwide. Facilities should verify protective grounding integrity and follow manufacturer instructions for corrective measures.
The recalled product
- Product
- Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 13
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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