Z-2685-2016Class II

RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to...

Name: Z-2685-2016 RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to...
Creator: Merge Healthcare, Inc.
Published: 2016-01-30
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-01-30 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality... on 2016-01-30. FDA classified it as Class II and gives the reason as "Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2685-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-30
Posted: 2016-08-29
Terminated: 2019-10-15
Recalling firm: Merge Healthcare Incorporated
Product: 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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 96 sites potentially have the affected versions for both products
Distribution: US Distribution to: CO and OK.
Product codes and lots: Versions V8.30.6, 8.30.6.1, 8.30.6.2, and 8.30.6.3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2685-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2685-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-29
Z-2686-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-29

Product code LLZ

K053281Class IIEvms (Enterprise Visual Medical System Software)Emageon, Inc. / cleared 2005-12-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)