The Recall Desk
HighFDA (Devices)·Z-1886-2016·Announced 2016-06-08

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.

What this means for you

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 su
Manufacturer
Siemens Healthcare Diagnostics Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
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

Distributed nationwide across the United States.

The notice also names 49 states specifically:

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 →

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