Recall Z-2796-2016 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
| Date | May 6, 2013 |
| Status | Terminated |
| Reason | Multiple studies were missing at a customer location that never made it to the archive before watermarking |
| Root cause | Software design |
| Action | The recalling firm first issued a letter via email dated May 6, 2013. A letter dated January 28, 2016, was also issued via email. Both letters informed the customer a software upgrade was available and of the issue and makes recommendations about using the software. They are also informed an upgrade is available to correct the issue. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. In addition, the customer is requested to call Customer Service or send them an email to schedule the upgr |
| Quantity | 45 sites potentially have the affected versions |
| Distribution | Distribution was nationwide to medical facilities. Government distribution was made to LA and OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053281 | EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) Emageon, Inc., Dec 7, 2005 |