Z-2796-2016Class II

RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI

Name: Z-2796-2016 RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI
Creator: Merge Healthcare, Inc.
Published: 2013-05-06
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2013-05-06 / 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 on 2013-05-06. FDA classified it as Class II and gives the reason as "Multiple studies were missing at a customer location that never made it to the archive before watermarking". 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-2796-2016
Classification: Class II
Status: Terminated
Initiated: 2013-05-06
Posted: 2016-09-14
Terminated: 2019-07-26
Recalling firm: Merge Healthcare Incorporated
Product: RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Multiple studies were missing at a customer location that never made it to the archive before watermarking
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 45 sites potentially have the affected versions
Distribution: Distribution was nationwide to medical facilities. Government distribution was made to LA and OK.
Product codes and lots: This potential patient safety issue is only present in the following versions when a reverse workflow is used: 2004-R6.x, 5.10.x, 5.20, 5.25, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, 5.35.4 HF0513, 5.35.4 HF0518, 5.35.4 HF0528, 5.35.4 HF0531, 5.35.4 HF0535, 5.35.4 HF0546, 8.30.0. NOTE: The standard workflow is not impacted. .

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2796-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2796-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-14

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)