Siemens Artis zee/zeego Systems Recalled for X-ray Locking Function Defect
Siemens Medical Solutions is recalling 586 Artis zee/zeego angiography systems because a system error could prevent users from exiting the X-ray locking function without a restart.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source describes a functional limitation requiring a system restart to exit a specific mode, but does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 586 Artis zee/zeego systems, which are dedicated angiography systems used for diagnostic imaging and interventional procedures. The recall is due to a software defect affecting the X-ray locking function.
If a system error occurs and the device enters "Bypass Fluoro" mode while the X-ray locking function is active, the only way to exit the locking function is to resolve the root cause of the error or to restart the system. This limitation may impact the ability to manage the device's state during specific operational conditions.
The affected units were distributed nationwide. Siemens Medical Solutions is the recalling firm. Users of these systems should contact Siemens for further instructions on resolving the issue or restarting the system as necessary.
The recalled product
- Product
- Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 586
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 (6)
- Model Numbers of device: 10094135
- 10094137
- 10094139
- 10094141
- 10094142
- 10094143
Distribution
Distributed nationwide across the United States.
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