Radiometer AQURE System Software Recalled for Patient View Display Error
Radiometer America Inc is recalling AQURE System software due to a design error that may cause users to misread patient parameters and values.
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 is classified as FDA Class II, and the hazard involves a risk of harm (misreading patient data) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Radiometer America Inc is recalling the AQURE System, software version 2.2.0, model number 933-599. This software is used to manage Radiometer blood gas and immunoassay analyzers and results from third-party devices for point-of-care testing in hospital settings. The recall involves 7 total units, with 2 located in the United States and the remainder distributed internationally to England, Switzerland, and the United Arab Emirates.
The recall is due to a design error in the patient view window that displays additional information. This error may result in a user misreading a specific parameter and its associated value. The system is intended for professional use to track connected devices, monitor performance, and associate patient data with test data.
No specific instructions for end-users are provided in the source text, as the product is intended for professional use in hospital environments. Affected facilities should contact the recalling firm for further instructions on resolving the software issue.
The recalled product
- Product
- AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital
- Manufacturer
- Radiometer America Inc
- Category
- Medical Device — Software
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)
- UDI: (01)05700699335999(10)2.2.0
Distribution
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