Recall Z-0108-2014 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Siemens Healthcare Diagnostics Inc
Siemens RAPIDLab 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH,
| 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 | 2939 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
| K073537 | NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 Siemens Medical Solutions Diagnostics, Jun 27, 2008 |