Recall Z-0137-2017 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
| Date | Jan 30, 2016 |
| Status | Terminated |
| Reason | The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in incorrect patient follow-up. |
| Root cause | Software design |
| Action | Merge Healthcare Inc. sent an Urgent Medical Device Recall letter dated January 28, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 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 upgrade. If the customer chooses not to upgrade, they are requested to complete the attached form or go online and complete it. |
| Quantity | 844 sites potentially have the affected versions |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution. Foreign/military/government distribution was also made. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092954 | CADSTREAM VERSION 5 Confirma, Inc., Nov 6, 2009 |