Siemens AXIOM Artis TC X-ray Generator Recall for Power Supply Issue
Siemens is recalling one AXIOM Artis TC unit due to a power supply tolerance issue that may cause X-ray generation failure during procedures.
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: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling one unit of the AXIOM Artis TC, Model Number 7728350, due to a tolerance issue in the power supply of the generator control. The affected unit has Serial Number 30006 and was distributed nationwide in the United States.
The issue may cause the generator A100 to fail, preventing the X-ray tube from receiving the required voltage. As a result, X-ray imaging may not be possible. The problem occurs sporadically and may arise during an ongoing procedure.
This recall is classified as Class II by the FDA. No injuries or illnesses have been reported in the source text. Healthcare facilities should contact Siemens for further instructions on resolving the issue.
The recalled product
- Product
- AXIOM Artis TC, Model Number 7728350
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — X-ray Equipment
- Hazard
- Affected units
- 1
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)
- Serial Numbers: 30006
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 23 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.
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