Siemens Atellica IM 1600 Analyzer Recalled for Software Issues
Siemens Healthcare Diagnostics is recalling 366 Atellica IM 1600 Analyzers due to multiple issues identified in the system software that required an update.
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, but the source text does not report any hospitalizations, injuries, or deaths, and the issue is a software update rather than a structural defect or high-risk pathogen.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 366 units of the Atellica IM 1600 Analyzer, Material Number 11066000. The recall was initiated because multiple issues were identified in the system software which required an update.
The affected products were distributed to 35 US states and Puerto Rico, as well as numerous foreign countries including Argentina, Australia, Canada, China, Germany, India, Japan, Mexico, and the United Kingdom. The specific UDI for the affected units is 00630414002026.
This recall is classified as Class II by the FDA. Users should contact Siemens Healthcare Diagnostics for further instructions regarding the software update.
The recalled product
- Product
- Atellica IM 1600 Analyzer, Material Number 11066000
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 366
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: 00630414002026
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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