Recall Z-1832-2014 ยท LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Siemens Medical Solutions Diagnostics
VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual tasks and consolidates results.
| Date | Jun 19, 2014 (initiated Apr 25, 2014) |
| Status | Terminated |
| Reason | The keyboard and monitor may not be properly secured to the monitor arm. |
| Root cause | Device Design |
| Action | Siemen's Healthcare Diagnostics sent an Urgent Medical Device Correction letter dated April 25, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return teh Field Correction Effectiveness Check form attached to the letter within 30 days by fax to 302-631-7597. Inspect the monitor, keyboard and bracket assembly. If the screw and washer assembly is secure as shown in Figure 1, the monitor and keyboard assembly is safe to use. After making adjustments or repositioning the moni |
| Quantity | 19 units |
| Distribution | Worldwide Distribution - USA including Iowa and New York and Internationally to Canada, Chile, France, India, Italy, Malaysia, Peru, Korea, and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970227 | IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER Dpc Cirrus, Apr 8, 1997 |