Recall Z-0878-2017 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
| Date | Dec 21, 2016 (initiated Oct 8, 2015) |
| Status | Terminated |
| Reason | Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment. |
| Root cause | Software design |
| Action | Merge issued a letter dated March 28, 2016, via email on April 4, 2016, or via certified mail if they did not have an email address for the customer. The letter notifies the customer of the issue, informs them of a workaround and that a fix is not yet available but they will be notified once one is available. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. T |
| Quantity | 30 sites potentially have the effected versions |
| Distribution | Distribution was made to medical facilities in CA, CO, CT, MA, MD, MN, MT, NE, NV, NY NJ, PA, SC, WA, and WI. Foreign distribution was made to Canada, as well as other countries. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022881 | CEDARA I-SOFTVIEW Cedara Software Corp., Oct 22, 2002 |