Siemens Dimension Vista 1500 Lab System Software Defect Recall
Siemens is recalling Dimension Vista 1500 systems due to a software defect that may cause the device to omit a rinse step, potentially leading to 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 involves a medical device defect that can lead to discrepant patient results, which is a risk-of-harm scenario where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics Inc. is recalling approximately 1,300 Dimension Vista 1500 Intelligent Lab Systems. The recall involves systems running on software versions V.3.6.1 SP1 or V.3.6.2. All serial numbers and lots are affected. The devices are in vitro diagnostic instruments used to determine analytes in human body fluids.
The recall is due to a confirmed software defect. In specific circumstances, the system may omit an aliquot probe rinse between sample aspirations when processing tubes in front-loaded Sample Racks. This defect can result in discrepant patient results.
The affected units were distributed nationwide to all 50 states, the District of Columbia, and Puerto Rico. Siemens Healthcare Diagnostics Inc. is the recalling firm. Users should contact Siemens for instructions on how to resolve the software issue.
The recalled product
- Product
- Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures…
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Affected units
- 1,300
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)
- All serial numbers are affected.
Distribution
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.
See all 2 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
- ModerateSiemens Dimension Vista Systems Recalled for Software Processing Errors
FDA (Devices) · 2015-07-15
- HighSiemens Dimension Vista 1500 Recalled for Potential Sample Contamination
FDA (Devices) · 2018-12-26
- ModerateSiemens Dimension Vista Diagnostic Vials Recalled for Volume Error
FDA (Devices) · 2013-12-11
- ModerateSiemens Dimension Vista Systems Recalled for Potential Sample Dispensing Error
FDA (Devices) · 2013-09-04
- ModerateSiemens Dimension Vista Lab Systems Recalled for Reagent Performance Issues
FDA (Devices) · 2014-12-31
- HighSiemens Dimension Vista 500 and 1500 Systems Recalled for Flex Assignment Error
FDA (Devices) · 2014-02-05