Artis zeego X-ray imaging system recalled for insufficient cooling
Siemens is recalling 183 Artis zeego X-ray imaging systems due to a cooling system defect that may prevent adequate X-ray tube cooling, triggering automatic system shutdown.
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 recall with no reported illnesses or injuries. The hazard is inadequate X-ray tube cooling that triggers automatic system shutdown. This is a risk-of-harm product where injury has not yet been reported, corresponding to High severity per the rubric.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 183 Artis zeego X-ray imaging systems (Model 10280959) distributed nationwide in the United States.
If the coolant level in the cooling circuit drops below required levels, the X-ray tube may not be adequately cooled. When this occurs, the system initially displays 'TUBE HOT, have a break' and subsequently blocks X-ray operation with a 'NO XRAY: TUBE TOO HOT' message to prevent further equipment damage.
Affected units can be identified by the UDI 4056869010083 and specific serial numbers listed in the FDA recall notice. Healthcare facilities should verify the serial numbers of their equipment against the recall list provided.
Users should contact Siemens Medical Solutions USA, Inc. for instructions on remediation or corrective actions for affected systems.
The recalled product
- Product
- Artis zeego, Model Number 10280959
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 183
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)
- UDI: 4056869010083
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 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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