Recall Z-1243-2007 ยท LLZ System, Image Processing, Radiological
Cerner Corp
Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities.
| Date | Sep 25, 2007 (initiated Aug 23, 2007) |
| Status | Terminated |
| Reason | Defects in the Auto Launch functionality make it possible for a mismatch of patient data. |
| Root cause | Software design |
| Action | The recalling firm initiated recall via telephone on 8/23/07 to their customers who had the 2007 version in their production environment, explained the reason for recall, and informed them they should turn off the affected functionality. The firm posted details of the situation on their website in two different documents (referred to as a Priority Review Flash), one dated 8/29/07 and the other dated 8/31/07. The 8/31/07 document was also mailed to their customers via certified mail on 9/4/07. The corrected software (EP28822 ver.1) was made available to the firm's clients on 9/7/07 via their |
| Quantity | Downloaded by 9 customers nationwide. |
| Distribution | Distribution was made to health care facilities located in LA, MO, NJ, MS, MI, NE, ND, and AR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022881 | CEDARA I-SOFTVIEW Cedara Software Corp., Oct 22, 2002 |