Siemens Atellica IM Humidity Pack Software Error Recall
Siemens Healthcare Diagnostics is recalling Atellica IM Humidity Packs due to a software error that 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 hazard is a software error causing incorrect ejection of humidity packs rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Atellica IM Humidity Packs (SMN 11313496, UDI 00630414243726) used with the Atellica IM analyzer. The recall affects units with Software Version V1.21.0 and lower. The product is intended for the qualitative and quantitative analysis of various body fluids using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology.
The recall is due to a software error that causes the analyzer to incorrectly eject affected Humidity Packs as expired. This issue may disrupt the maintenance of reagent compartment humidity, which is intended to be maintained between 70% and 100%.
The affected product was distributed domestically nationwide and worldwide. Siemens Healthcare Diagnostics, Inc. is the recalling firm. Users should contact the manufacturer for further instructions regarding the software update or replacement of the affected packs.
The recalled product
- Product
- Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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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