Siemens Atellica IM 1300 Analyzer Recalled for Software Issues
Siemens Healthcare Diagnostics is recalling 277 Atellica IM 1300 Analyzers due to multiple issues identified in the system software that required an update.
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. The source text does not report any hospitalizations, injuries, or deaths, and the issue is a software defect requiring an update, which aligns with the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 277 units of the Atellica IM 1300 Analyzer, Material Number 11066001. The recall was initiated because multiple issues were identified in the system software which required an update.
The affected products were distributed to numerous US states, including Alabama, Arizona, California, Florida, New York, and Texas, as well as Puerto Rico. The products were also distributed to foreign countries including Argentina, Australia, Canada, Germany, India, Japan, and the United Kingdom.
Healthcare facilities and consumers who possess this specific analyzer should contact Siemens Healthcare Diagnostics for instructions on how to obtain the necessary software update. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Atellica IM 1300 Analyzer, Material Number 11066001
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 277
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)
- UDI: 00630414007960
Distribution
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.
See all 3 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · software defect
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighSiemens Recalls Atellica IM 1300 Analyzer Software Due to Multiple Issues
FDA (Devices) · 2019-02-06
- HighSiemens Atellica IM 1300 Analyzer Software Recall for Reagent Lot Scanning Issues
FDA (Devices) · 2019-10-30
- HighSiemens Atellica IM 1300 Analyzer Software Recall for Discrepant Results
FDA (Devices) · 2021-01-20
- HighSiemens Atellica IM 1600 Analyzer Software Recall for Reagent Lot Scanning Issues
FDA (Devices) · 2019-10-30
- HighSiemens Atellica Analyzer Software Recall for Multiple System Issues
FDA (Devices) · 2019-02-06
- HighAtellica IM 1300 Analyzer Valves Recalled Due to Manufacturing Defect
FDA (Devices) · 2021-07-14