ELITech Viva-ProE Systems Recalled for Software Malfunction
ELITech Group B.V. is recalling 89 Viva-ProE Systems because a software malfunction causes the devices to become inoperable.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a software malfunction causing inoperability, with no reported injuries or illnesses.
Plain-English summary
ELITech Group B.V. is recalling 89 units of the Viva-ProE Systems, Model # 6003-670. These automated clinical chemistry systems are intended for use in clinical laboratories to perform various assay methods using spectrophotometric and electrochemical techniques.
The recall is being conducted because the devices are subject to a software malfunction that causes them to become inoperable due to a software lockup. The affected units were distributed nationwide in the United States, including the state of New York.
The source text does not specify instructions for consumers or healthcare facilities regarding the next steps for these devices.
The recalled product
- Product
- Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been…
- Manufacturer
- ELITech Group B.V.
- Hazard
- Affected units
- 89
Distribution
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