Z-2159-2016Class II

Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI

Name: Z-2159-2016 Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI
Creator: Merge Healthcare, Inc.
Published: 2016-01-31
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-01-31 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI on 2016-01-31. FDA classified it as Class II and gives the reason as "Potential data loss occurs as a result of product archiving not working properly". 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-2159-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-31
Posted: 2016-07-11
Terminated: 2017-01-26
Recalling firm: Merge Healthcare Incorporated
Product: Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Potential data loss occurs as a result of product archiving not working properly.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/31/2016 explaining the reason for recall and instructing the customer to provide a copy of the notification to all users.
Quantity in commerce: 49 sites have the affected software
Distribution: Distribution was made to medical facilities located in AL, AZ, CA, CO, CT, FL GA, ID, IL, KY, MA, MO, NE, NH, NJ, NY, NC, OK, PA, SC, TN, VA, and WA. There was no government/military/foreign distribution.
Product codes and lots: Version 3.4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2159-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2159-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11

Product code LLZ

K033825Class IIOrthopacsEtrauma.Com Corp. / cleared 2004-02-02

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)