RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA Recall Z-2796-2016 · Posted None
Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2013-05-06
Date Terminated2019-07-26
Product Quantity45 sites potentially have the affected versions
Reason for Recall
Multiple studies were missing at a customer location that never made it to the archive before watermarking
Firm 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 upgrade. If the customer chooses not to upgrade, they are requested to complete the attached form or go online and complete it.
For further questions please call (800) 724-5970 Ext. 8027.
Root Cause
Software design
Distribution Pattern
Distribution was nationwide to medical facilities. Government distribution was made to LA and OK.
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.