Recall Z-0103-2014 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose,
| Date | Oct 29, 2013 (initiated Sep 17, 2012) |
| Status | Terminated |
| Reason | RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Siemens Healthcare sent an Urgent Field Safety Notification letter dated September 2013 via Federal Express, to affected Siemens domestic customers. Effected Siemens customers outside the US was provided a copy of the Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each countries local regulations and procedures. Previously Siemens Healthcare had issued a Customer Notification on August 23, 2012. The letter identified the affected product, issue, information to mitigate the issue and actions to be taken. The firm will issue an upgrades software to users. For q |
| Quantity | 4494 units |
| Distribution | Worldwide Distribution - USA Nationwide and in the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Brazil, Brunei, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Fren.Polynesia, Germany, Greec |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110277 | RAPIDPOINT 405 NEONATAL BILIRUBIN Siemens Healthcare Diagnostics, Aug 15, 2011 |