Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Data Integrity Issues
Siemens is recalling RAPIDPoint 500 Blood Gas Analyzers because simultaneous use of Serial and Ethernet ports may cause data duplication, loss, or patient mismatch.
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 high-risk medical device where a defect could lead to incorrect patient data (mismatched or missing results), representing a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 5,241 units of the RAPIDPoint 500 Blood Gas Analyzer. The affected units were shipped between October 2011 and June 2015 and have serial numbers in the range of 30003 to 37040 (not inclusive). The devices are identified by Siemens Material Numbers 10492730, 10696855, 10696857, and 10697306.
The recall is due to a potential data integrity issue. When both the Serial and Ethernet ports are configured to transmit data, the data stream from one port could affect the data stream from the other. This interference may cause the data management system to include duplicate data, missing data, or data from a different patient.
The affected products were distributed worldwide, including in the United States and numerous international markets. Users should check their device serial numbers against the affected range and contact Siemens Healthcare Diagnostics Inc for further instructions on remediation.
The recalled product
- Product
- RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 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
- 5,241
Distribution
Distributed nationwide across the United States.
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