Siemens Dimension Vista 500 Lab System Software Defect Recall
Siemens recalls Dimension Vista 500 systems due to a software defect that may omit probe rinses, potentially causing 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, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics Inc. is recalling the Dimension Vista 500 Intelligent Lab System. The recall affects units running software versions V.3.6.1 SP1 or V.3.6.2, with all serial numbers and lots included. Approximately 1,301 units were distributed nationwide to various states and Puerto Rico.
The recall is due to a confirmed software defect that, in specific circumstances, causes the system to omit an aliquot probe rinse between sample aspirations when processing front-loaded sample racks. This malfunction can result in discrepant patient results.
Healthcare facilities using these systems should contact Siemens Healthcare Diagnostics for instructions on how to address the software defect and ensure accurate diagnostic results.
The recalled product
- Product
- Dimension Vista 500 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
- 1,301
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.
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