Recall Z-0215-2019 ยท LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Siemens Healthcare Diagnostics, Inc.
STREAMLAB CORE UNIT / LYNX WITH IOM
| Date | Aug 14, 2018 |
| Status | Terminated |
| Reason | The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Correction notification letters dated 8/14/18 were distributed to customers. |
| Quantity | 186 StreamLAB Automation Modules |
| Distribution | The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WV. The products were distributed to the following foreign countries: Australia, Austri |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082638 | ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL Siemens Healthcare Diagnostics, Inc., Feb 26, 2009 |