Diagnostic imaging system software malfunction may interrupt clinical procedures
Siemens is recalling 35 Artis icono floor diagnostic imaging systems due to five potential software errors affecting equipment movements and detector control. The defects may limit functionality during procedures and could delay clinical treatment until the system is restarted.
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 documented software defects that may impair clinical functionality during procedures. No injuries or hospitalizations have been reported. The hazard represents a risk-of-harm scenario involving potential treatment delay and clinical interruption.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 35 units of the Artis icono floor diagnostic and interventional imaging system (Model 11327700). The devices are affected by five potential software errors related to block movements and manual flat detector rotation.
The software defects may result in limited functionality during clinical procedures. When this occurs, the equipment may be unable to continue treatment as planned, potentially requiring a system restart to restore operation and resume the procedure.
Healthcare facilities with affected serial numbers should contact Siemens Medical Solutions USA, Inc. for guidance on remediation and to verify whether their equipment is included in this recall. Affected units were distributed nationwide in the United States.
The recalled product
- Product
- Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 35
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
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