Siemens Atellica CH 930 Analyzer Software Recall for Discrepant Results
Siemens Healthcare Diagnostics is recalling Atellica CH 930 Analyzers with software version 1.23.2 or lower because multiple software issues may lead to the reporting of discrepant patient results.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where the hazard is the reporting of discrepant patient results, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 2,405 units of the Atellica CH 930 Analyzer. The recall affects units equipped with software version 1.23.2 (SMN 11469032) or lower. The Atellica CH 930 Analyzer is an in vitro diagnostic device intended for the qualitative and quantitative analysis of various body fluids using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
The recall was initiated because multiple issues in the affected software versions may lead to the reporting of discrepant patient results. The agency has classified this as a Class II recall. The affected units were distributed worldwide, including nationwide distribution in the United States and in numerous other countries.
Healthcare facilities and users of the Atellica CH 930 Analyzer should contact Siemens Healthcare Diagnostics, Inc. for instructions on how to resolve the software issues. Users should verify their software version to determine if their units are affected by this recall.
The recalled product
- Product
- Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 2,405
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)
- Software (SW) versions V1.23.2 (SMN 11469032) or lower
Distribution
Distributed nationwide across the United States.
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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