Z-2531-2016Class II

iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality...

Name: Z-2531-2016 iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality...
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 iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data... on 2016-01-30. FDA classified it as Class II and gives the reason as "Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after...". 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-2531-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-30
Posted: 2016-08-12
Terminated: 2021-05-07
Recalling firm: Merge Healthcare Incorporated
Product: iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued a letter dated 1/28/2016 via e-mail on 1/31/2016 or via certified mail if they did not have an e-mail address for the customer.
Quantity in commerce: 146 sites potentially have the affected versions for both products
Distribution: Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand. There was no military or government distribution.
Product codes and lots: iConnect Access V4.0 or earlier with any version of Merge PACS and iConnect Access V4.1 with Merge PACS V6.5.4 or earlier

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2531-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2531-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-12
Z-2532-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-12

Product code LLZ

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)