RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
FDA Recall Z-2685-2016 · Posted None
Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-01-30
Date Terminated2019-10-15
Product Quantity96 sites potentially have the affected versions for both products
Reason for Recall
Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.
Firm Action
The firm, Merge, sent an "URGENT: MEDICAL DEVICE RECALL" letters dated 1/29/2016 and 5/25/2016 via e-mail or via certified mail if they did not have an e-mail address for the customers. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: you must discontinue using the affected version of RadSuite or iConnect Enterprise Archive with GE AW Workstation; use the workaround listed in the letter; complete and return the enclosed form no later than June 17, 2016; ensure that all users of the product are provided with the notification; if you have further distributed this product, please identify your customers and notify them at once of this product recall
Merge has a released fix available for this issue.
If you have any additional questions, please send an email to [email protected] or call 800-724-5970 ext 8027.
Root Cause
Software design
Distribution Pattern
US Distribution to: CO 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.