Siemens Artis zee multi X-ray generator power supply recall
Siemens is recalling 89 Artis zee multi units because a power supply issue may cause the X-ray generator to fail 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 the hazard involves a risk of harm (procedure interruption) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 89 units of the Artis zee multi, Model Number 10094139. The recall is due to a tolerance issue in the power supply of the generator control. This issue may cause the generator A100 to fail, resulting in the X-ray tube not receiving the required voltage and making X-ray imaging impossible.
The issue occurs sporadically but may happen during an ongoing procedure. The affected units were distributed nationwide in the United States. The recall is classified as Class II by the FDA.
Hospitals and medical facilities should identify affected units by checking the serial numbers listed in the official recall notice. Siemens is the recalling firm and is responsible for managing the recall process.
The recalled product
- Product
- Artis zee multi, Model Number 10094139
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — X-ray Equipment
- Hazard
- Affected units
- 89
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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