Siemens Atellica IM 1300 Analyzer Recalled for Software Issues
Siemens Healthcare Diagnostics is recalling 277 Atellica IM 1300 Analyzers due to multiple issues identified in the system software that required an update.
What this means for you
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 text does not report any hospitalizations, injuries, or deaths, and the issue is a software defect requiring an update, which aligns with the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 277 units of the Atellica IM 1300 Analyzer, Material Number 11066001. The recall was initiated because multiple issues were identified in the system software which required an update.
The affected products were distributed to numerous US states, including Alabama, Arizona, California, Florida, New York, and Texas, as well as Puerto Rico. The products were also distributed to foreign countries including Argentina, Australia, Canada, Germany, India, Japan, and the United Kingdom.
Healthcare facilities and consumers who possess this specific analyzer should contact Siemens Healthcare Diagnostics for instructions on how to obtain the necessary software update. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Atellica IM 1300 Analyzer, Material Number 11066001
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 277
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: 00630414007960
Distribution
Part of a larger recall action
This product is one of 3 recalled by Siemens Healthcare Diagnostics, 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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