X-Ray System Recalled for Potential Excessive Radiation Dose in First Image
Siemens ARTIS One X-ray systems may deliver higher radiation doses during first imaging after patient registration due to copper prefiltration malfunction occurring in very rare situations.
What this means for you
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 recall with no reported deaths, injuries, or illnesses. The hazard is potential excessive radiation exposure if prefiltration malfunction occurs in very rare situations. This constitutes a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The ARTIS One Angiographic X-Ray System has been recalled by manufacturer Siemens Medical Solutions USA, Inc. due to a potential issue affecting x-ray prefiltration settings.
In very rare situations, the first x-ray image taken following patient registration may be performed with incorrect copper prefiltration. This malfunction could result in a higher radiation dose-rate being applied than the operator intended, exposing patients to unplanned radiation exposure.
Healthcare facilities using these systems should contact Siemens Medical Solutions USA, Inc. for guidance on inspection and remediation. Patients who may have received imaging on affected systems should consult with their healthcare provider if they have concerns about radiation exposure.
The recalled product
- Product
- ARTIS One Angiographic X-Ray System
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS USA, INC
- Affected units
- 1,140
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)
- Model Number 10848600
Distribution
Distribution scope not specified by the agency.
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