Agency classClass IIOur severity:High FDA (Devices)·Z-0780-2019·Announced 2019-02-06

Siemens Recalls Atellica IM 1300 Analyzer Software Due to Multiple Issues

Siemens Healthcare Diagnostics is recalling 217 Atellica IM 1300 Analyzers worldwide due to multiple issues identified in software version 1.14.2 and lower.

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, which typically corresponds to a High severity score (3) when no specific hospitalizations or severe injuries are reported in the source text.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 217 units of the Atellica IM 1300 Analyzer. The recall covers the Atellica Solution System software in version 1.14.2 and lower. The affected products are intended for in vitro diagnostic testing of clinical specimens using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology.

The recall was initiated because multiple issues were identified in the software. The source text does not specify the exact nature of these software issues or the specific clinical consequences they may cause. The affected analyzers were distributed worldwide, including in the United States and numerous international markets such as Australia, Canada, and the United Kingdom.

Healthcare facilities and users of the Atellica IM 1300 Analyzer should contact Siemens Healthcare Diagnostics for instructions on how to address the software issues. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - 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 Diagnostics
Hazard: software-defect
Affected units: 217

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