Dimension Vista(R) 500 and Dimension Vista(R) 1500 -… recallZ-0430-2014 · Siemens Healthcare Diagnostics, Inc. · initiated May 20, 2013
Class II Terminated All recalls posted in December 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1
FDA root cause category: Software design
What the company is doing
A notification letter was sent to consignees in May 2013.
Recall details
- Recall number
- Z-0430-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 20, 2013
- Posted by the FDA
- Dec 2, 2013
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 776
- Product code
- JJE
- FDA submissions
- K051087
- Distribution
- Worldwide Distribution: USA (nationwide) and iinternationally to Canada.
Product description
Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids.
Code information (models, lots, serial numbers)
Dimension Vista(R) 500 - Siemens Material Number 10284473 and Dimension Vista(R) 1500 - Siemens Material Number 10444801
Other devices under the same FDA submission
4 devices cleared under K051087 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dimension Vista® 500 10284473Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall524 reports
- Dimension Vista® 500 Intelligent Lab System 10488217Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE13 reports
- Dimension Vista® V-LYTE® Integrated Multisensor Na+ / K+ / Cl- 10484429Siemens Healthcare Diagnostics Inc. · ELECTRODE, ION SPECIFIC, POTASSIUM10 reports
- Dimension Vista® 1500 Intelligent Lab System 10459469Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE9 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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