Agency classClass IIOur severity:High FDA (Devices)·Z-0782-2019·Announced 2019-02-06

Siemens Atellica Analyzer Software Recall for Multiple System Issues

Siemens Healthcare Diagnostics is recalling Atellica analyzer software versions 1.14.2 and lower due to multiple identified issues affecting in vitro diagnostic testing.

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 involves a medical device with 'multiple issues' identified in the software, representing a risk-of-harm product where specific injury or illness has not yet been reported in the source text, fitting the High severity criteria.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the Atellica Solution System software, specifically versions 1.14.2 and lower. The recall involves the Atellica IM 1300 Analyzer, Atellica IM 1600 Analyzer, Atellica CH 930 Analyzer, and Atellica Sample Handler Prime. These devices are used for the qualitative and quantitative analysis of various body fluids for clinical use.

The recall was initiated because multiple issues were identified in the software. The source text does not specify the exact nature of these software defects or the specific clinical consequences they may cause. The recall covers 490 units distributed worldwide, including the United States and numerous international locations such as Australia, Canada, and various European and Asian countries.

Healthcare facilities and laboratories using these systems should contact Siemens Healthcare Diagnostics for instructions on how to resolve the software issues. The source text does not provide specific consumer action steps beyond the general recall notification.

The recalled product

Product: Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the…
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostic Analyzer
Hazard: software-defect
diagnostic-error
Affected units: 490

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 in V 1.14.2 and lower.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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.

See all 4 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

See all →

High
Siemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
Severe
Siemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
Severe
Siemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
High
Siemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
Low
Syva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12

Same hazard · software defect