Z-2123-2017Class II

Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to...

Name: Z-2123-2017 Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to...
Creator: Merge Healthcare, Inc.
Published: 2016-04-13
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-04-13 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive... on 2016-04-13. FDA classified it as Class II and gives the reason as "Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's MRN, resulting in the wrong fetal measurements getting referenced". 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-2123-2017
Classification: Class II
Status: Terminated
Initiated: 2016-04-13
Posted: 2017-05-22
Terminated: 2017-07-17
Recalling firm: Merge Healthcare Incorporated
Product: Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's MRN, resulting in the wrong fetal measurements getting referenced.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued a "Medical Device Correction" letter dated 4/13/2016 via e-mail. The letter identified the affected product, issue involved, potential harm, a work around, as well as the actions to be performed by both the customer and firm. Merge Technical Support will contact customers to discuss the fix. Customers are to ensure that all users are provided the notice. If the affected product was further distributed, those customers should be identified and notified of the issue. A copy of the notice may be provided to those customers. If there are additional questions, customers can e-mail [email protected].
Quantity in commerce: 30 sites have the potentially affected software versions
Distribution: Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.
Product codes and lots: Versions 10.0, 10.0.1, 10.1, 10.1.1,10.1.1.1, and 10.1.2.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2123-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2123-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-22

Product code LLZ

K051649Class IIVericis Cardiovascular Image and Information System, Model 4.0Camtronics Medical Systems / cleared 2005-08-02

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)