Recall Z-0409-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension EXL 200 00630414593579; Dimension EXL with LM 00630414593500; Dimension EXL with LM with STM 00630414593593; Dimension RxL Max 00630414949789; Dimension RxL Max HM 00630414949796; Dimension RxL Max HM STM 00630414949819; Dimension Xpand Plus 00630414949833; Dimension Xpand Plus HM 00630414949840; Dim
| Date | Sep 28, 2018 |
| Status | Terminated |
| Reason | Thermal chamber motors have electrical cables with single insulation rather than the required double insulation. There is no exposed current due to the single insulation that could result in a potential electrical shock |
| Root cause | Device Design |
| Action | The firm, Siemens Healthcare, issued on 09/28/2018, "Urgent Medical Device Correction" DI-18-02.A.US (US customers)/Urgent Field Safety Notice DI-18-02.A.OUS ( for OUS customers), informing them of the issue and providing them with the steps Siemens is taking to correct the issue. A Siemens Service Engineer will schedule a Service visit to inspect the instrument and install a protective cover, if necessary, to correct the issue. Customers were instructed to perform the following actions: "Please arrange a time for your system upgrade when contacted by Siemens. "Return completed Field Correc |
| Quantity | 277 units |
| Distribution | Worldwide Distribution: US (Nationwide) and countries of: Algeria, Argentina, Australia, Brazil, Canada, China, Columbia, Croatia, Egypt, France, Germany, Great Britain, Greece, Hungary, India, Italy, Japan, Malaysia Mexico, Netherlands, Poland, Portugal, Russia, Saudi Arabia, Slovenia, South Africa |
| FDA record | Open on fda.gov |