RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA Recall Z-2627-2016 · Posted 2016-08-23
Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-01-31
Date Terminated2017-02-10
Product Quantity25 sites potentially have the affected versions
Reason for Recall
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.
Firm 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 form or go online and complete it. If you have any additional questions call Merge Customer Service at (877) 741-5369.
For further questions, please call (262) 367-0700.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.