Recall Z-0590-2017 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Aptio Automation Modules
| Date | Sep 29, 2016 |
| Status | Terminated |
| Reason | Possible overheating of power cord plugs used to connect to FlexLab and Aptio Automation systems. |
| Root cause | Under Investigation by firm |
| Action | Siemens mailed to customers an Urgent Field Safety Notification letter warning them of the problem and to inform them that Siemens Customer Service Engineers shall be visiting customer sites to replace the power cords. |
| Quantity | 448 units |
| Distribution | Distributed Nationwide and to the following countries: Australia, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Canada, Czech Republic, Denmark, Egypt, Germany, Greece, Indonesia, Italy, Kingdom Saudi Arabia, Lebanon, Malaysia, P.R. China, Philippines, Portugal, Qatar, Republic Korea, Saudi Arab |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.