Z-0599-2017Class II

Merge PACS software

Name: Z-0599-2017 Merge PACS software
Creator: Merge Healthcare, Inc.
Published: 2016-03-28
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-03-28 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and... on 2016-03-28. FDA classified it as Class II and gives the reason as "The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing". 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-0599-2017
Classification: Class II
Status: Terminated
Initiated: 2016-03-28
Posted: 2016-11-17
Terminated: 2021-04-23
Recalling firm: Merge Healthcare Incorporated
Product: Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued a letter dated March 28, 2016 via e-mail or via certified mail to customers. The letter identified the affected product, problem and actions to be taken. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope.
Quantity in commerce: 534 sites potentially have the affected versions
Distribution: Worldwide Distribution - US Nationwide including Canada.
Product codes and lots: Versions: V6.0 MR2, 6.0 MR3, 6.0 MR3 CU, 6.0 MR4, 6.0 MR4 CU1, 6.0 MR4 CU2, 6.0 MR4 CU3, 6.0 MR4 CU4, 6.0 MR4 CU5, 6.0 MR4 CU6, 6.0 MR4, CU7, 6.0 MR4 CU8, 6.0 MR4 CU9, 6.0 MR4 CU10, 6.0 MR4 CU11, 6.1, 6.1.1, 6.1.2, 6.1.3, 6.2, 6.2.1, 6.2.2, 6.2.3, 6.2.4, 6.2.5, 6.3, 6.4, 6.4.1, 6.4.2, 6.4.3, 6.4.4, 6.4.5, 6.4.6, 6.4.7, 6.5, 6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9, 6.6, 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, 7.0.1, and 7.0.2.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0599-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0599-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16

Product code LLZ

K082144Class IIAmicas Pacs, Version 6.0Amicas, Inc. / cleared 2008-09-05

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)