Z-0294-2017Class II

Fusion Workstation.; Indicated for the transmission and review of radiological images

Name: Z-0294-2017 Fusion Workstation.; Indicated for the transmission and review of radiological images
Creator: Merge Healthcare, Inc.
Published: 2011-10-28
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2011-10-28 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Fusion Workstation.; Indicated for the transmission and review of radiological images on 2011-10-28. FDA classified it as Class II and gives the reason as "After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values". 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-0294-2017
Classification: Class II
Status: Terminated
Initiated: 2011-10-28
Posted: 2016-10-20
Terminated: 2016-12-14
Recalling firm: Merge Healthcare Incorporated
Product: Fusion Workstation.; Indicated for the transmission and review of radiological images.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm initiated phone calls to affected sites beginning 1/30/2016.
Quantity in commerce: 13 sites potentially hae the affected version
Distribution: Distribution was made to AZ, CA, ID, IL, IN, MI, MN, and NJ.
Product codes and lots: Versions V3.0.2 P3, 3.02, 3.1, 3.2, 3.3, and 3.3.1.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0294-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0294-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20

Product code LLZ

K983401Class IIFramewave WebMl Strategies, Inc. / cleared 1998-12-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)