Recall Z-1615-2015 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimension Xpand Plus HM. The Dimension EXL clinical chemistry system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme
| Date | May 14, 2015 (initiated Apr 2, 2015) |
| Status | Terminated |
| Reason | Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been installed with a non-standard instrument power plug.The use of a non-standard plug configuration as described may lead to a potential electrical hazard. The likelihood of potential clinical impact or injury due to this issue is extremely low. |
| Root cause | Under Investigation by firm |
| Action | Siemens sent an Urgent Field Safety Notice, dated April 2015, was issued for distribution to affected customers in Japan to notify them of the issue. A Siemens Service Representative will visit customer sites to inspect the Dimension instrument power plug and wall outlet configuration. If the instrument is configured with a non-standard 15 Amp plug/outlet or a 20 Amp twist lock plug, Siemens will correct the issue identified, ensuring that the system is installed according to the instrument requirements. |
| Quantity | 17801 |
| Distribution | Distributed in the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073604 | DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD Dade Behring, Inc., Mar 13, 2008 |
| K112999 | DIMENSION CLINICAL CHEMISTRY SYSTEM Siemens Healthcare Diagnostics, Nov 22, 2011 |
| K130276 | DIMENSION EXL WITH LM SYSTEM Siemens Healthcare Diagnostics, Inc., Mar 22, 2013 |