Recall Z-2627-2016 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
| Date | Aug 23, 2016 (initiated Jan 31, 2016) |
| Status | Terminated |
| Reason | Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than the first viewport. |
| Root cause | Software design |
| Action | Merge Healthcare sent an Urgent Medical Device Recall letter dated January 28, 2016, and via email on January 31, 2013, 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 for |
| Quantity | 25 sites potentially have the affected versions |
| Distribution | Distribution was made to AL, AZ, CA, IL, MD, MA, MI, MO, NV, NJ, NC, OH, PA, TN, and VA. Government distribution was made to OK. There was no foreign/military distribution. |
| 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 |