Radiometer ABL90 FLEX Analyzer Recalled for Software Security Vulnerabilities
Radiometer America Inc is recalling ABL90 FLEX Analyzers due to software security vulnerabilities that may cause device shutdowns or reboots, potentially delaying medical treatment.
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 risk-of-harm product where the hazard is delayed medical treatment due to device malfunction, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Radiometer America Inc is recalling 13,042 units of the ABL90 FLEX Analyzer (REF 393090, UDI:05700693930909) due to software security vulnerabilities in the device's operating system. The affected units are those operating on system versions RXPE-UIM2743 v1.3XXXXXX or RXPE-UIM910 v1.3.XXXXXX.
The recall is being initiated because these software vulnerabilities may cause the device to shutdown or reboot unexpectedly. Such interruptions can result in delayed medical treatment for patients relying on the analyzer for diagnostic results.
The affected devices were distributed across 37 U.S. states and territories, as well as numerous international locations including Canada, the United Kingdom, Germany, and Japan. Healthcare facilities and users of these analyzers should contact Radiometer America Inc for further instructions on how to address the software vulnerabilities.
The recalled product
- Product
- ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
- Manufacturer
- Radiometer America Inc
- Affected units
- 13,042
Distribution
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