Recall Z-2479-2015— Siemens Healthcare Diagnostics Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2015-07-28, terminated 2017-02-17. It names 4 FDA 510(k) clearances: K113216, K110277, K020616 and 1 more. 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.. Reason: When both ports (Serial and Ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other port causing the data management system to include either: duplicate data, missing data, or data from a different patient..
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-28
- Terminated
- 2017-02-17
- Firm location
- Norwood, MA, United States
510(k) clearances named in this recall
4 on FDA's record- K113216 — RAPIDPOINT 500 BLOOD GAS ANALYER
- K110277 — RAPIDPOINT 405 NEONATAL BILIRUBIN
- K020616 — BAYER RAPIDPOINT 405 SYSTEM
- K002738 — BAYER RAPIDPOINT 400 SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
When both ports (Serial and Ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other port causing the data management system to include either: duplicate data, missing data, or data from a different patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.