Recall Z-2159-2016 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
| Date | Jul 11, 2016 (initiated Jan 31, 2016) |
| Status | Terminated |
| Reason | Potential data loss occurs as a result of product archiving not working properly. |
| Root cause | Software design |
| Action | The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/31/2016 explaining the reason for recall and instructing the customer to provide a copy of the notification to all users. |
| Quantity | 49 sites have the affected software |
| Distribution | Distribution was made to medical facilities located in AL, AZ, CA, CO, CT, FL GA, ID, IL, KY, MA, MO, NE, NH, NJ, NY, NC, OK, PA, SC, TN, VA, and WA. There was no government/military/foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033825 | ORTHOPACS Etrauma.Com Corp., Feb 2, 2004 |