Recall Z-2087-2016 ยท LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Siemens Healthcare Diagnostics Inc.
Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge Module (10703032 or 10713761) FlexLab High Throughput Centrifuge Module (11171747) FlexLab and Aptio Centrifuge Module (10628157 or 11266581): Used to separate substances according to their densities.
| Date | May 11, 2016 |
| Status | Terminated |
| Reason | Premature bucket failures |
| Root cause | Under Investigation by firm |
| Action | Siemens mailed to customers an Urgent Medical Device Correction (UMDC#LAI16-02.A.US) Urgent Field Safety Notification letter informing customers of the problem with recommendations to follow the existing maintenance instructions in the product operator manuals as well as a new requirement to spin at cycle speeds not exceeding 3500 rpm. |
| Quantity | 487 |
| Distribution | Nationwide: AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, WI, WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.