Z-0726-2017Class II

Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft...

Name: Z-0726-2017 Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft...
Creator: Merge Healthcare, Inc.
Published: 2016-03-28
License: https://open.fda.gov/license/

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

FDA source

Merge Healthcare, Inc. began a recall of Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies... on 2016-03-28. FDA classified it as Class II and gives the reason as "Cut lines on the image may present horizontally rather than vertically". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0726-2017
Classification: Class II
Status: Terminated
Initiated: 2016-03-28
Posted: 2016-12-08
Terminated: 2021-05-07
Recalling firm: Merge Healthcare Incorporated
Product: Merge PACS software. 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: Cut lines on the image may present horizontally rather than vertically.
Root cause tag: design
FDA root cause: Component design/selection
Action: MERGE sent an Urgent Medical Device Recall dated March 28, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Merge Healthcare is working on correcting the issues and will inform customers once a fix is made available. Customers were asked to reply using the enclosed form and the return addressed envelope. If customers have further distributed the affected product they need to identify their customers and notify them at once of the product recall. Customers with questions were instructed to send an email to [email protected].
Quantity in commerce: 537 sites potentially have the affected versions
Distribution: Worldwide Distribution - US (nationwide) Canada and foreign distribution
Product codes and lots: Versions V6 GA, 6.0 MR1, V6 MR1 CU1,V6 MR1 CU1 SF1, V6 MR1 CU4, V6 MR1 CU5, V6 MR1 CU6, V6 MR1 CU7,V6 MR1 CU8, 6.0 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-0726-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0726-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-08

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)