Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Patient ID Error
Siemens is recalling 159 RAPIDPoint 500 Blood Gas Analyzers because a blank patient ID field may cause demographic errors.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a software error leading to potential demographic data issues rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity recall.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 159 units of the RAPIDPoint 500 Blood Gas Analyzer with v2.4 software. The recall is due to a potential patient demographic error that can occur when the patient ID field is blank. The affected devices are used in professional point-of-care or laboratory environments to test blood gases, electrolytes, metabolites, and hemoglobin derivatives.
The affected units were distributed nationwide and in foreign countries including Australia, Bangladesh, Chile, Colombia, France, Germany, Hong Kong, India, Ireland, Japan, Latvia, Mexico, Spain, Switzerland, Thailand, and Uruguay. The recall is identified by FDA recall number Z-2040-2017.
Healthcare professionals should check their device serial numbers against the list provided in the official recall notice. If a device is affected, they should contact Siemens Healthcare Diagnostics Inc for instructions on how to proceed.
The recalled product
- Product
- RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.…
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 159
Distribution
Distributed nationwide across the United States.
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