Siemens Atellica IM Humidity Pack Recall Due to Software Error
Siemens Healthcare Diagnostics is recalling Atellica IM Humidity Packs because a software error causes the analyzer to incorrectly eject them as expired.
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 illnesses, and the defect is a software error causing incorrect ejection rather than a direct physical hazard.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Atellica IM Humidity Packs (SMN 11313505, UDI 00630414234526) with software version V1.21.0 and lower. The recall involves 2,149 units distributed domestically nationwide and worldwide.
The recall is due to a software error that causes the analyzer to incorrectly eject affected Humidity Packs as expired. These packs are intended to maintain reagent compartment humidity between 70-100% for the qualitative and quantitative analysis of various body fluids.
The source text does not specify reported illnesses or injuries. Users should contact Siemens Healthcare Diagnostics for instructions on how to proceed.
The recalled product
- Product
- Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 2,149
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)
- Lot 0010
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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