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Merge OrthoPACS recallZ-2063-2019 · Merge Healthcare, Inc. · initiated Jul 11, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Merge Healthcare, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).

FDA root cause category: Software Design Change

What the company is doing

Merge Healthcare notified customers on about 07/11/2019 via "Urgent Field Safety Notice" letter. The notice informed customers of two possible issues that may occur on Merge PACS and Merge OrthoPACS: 1. Prior thumbnails may not display in reverse chronological order. 2. Images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Use of an out of order image may result in the implementation of an incorrect or unnecessary treatment plan such as unnecessary medication, change in dosage of existing medication, or unnecessary medical procedures. It may also lead to progression of an existing patient condition, which may result in the progression of a disease state. Merge Healthcare will provide a software correction for the issue. A Merge Healthcare representative will contact each customer schedule the correction. In the interim, Merge Healthcare instructed customers that they can continue to use their Merge PACS/OrthoPACS devices by following the below instructions: 1. When pulling a series from thumbnail bar, confirm that the date of each series is visible in the viewport. The date will appear when overlays are configured to display the date. An administrator can assist in configuring Merge PACS/OrthoPACS if needed. 2. When utilizing the mammography scroll stacking tool, confirm that the date of each series is visible in the viewport. The date will appear when overlays are configured to display the date. An administrator can assist in configuring Merge PACS/OrthoPACS if needed. Customers were instructed to use the date, rather than the order the series are presented in, to determine chronological order. Additional instructions included to ensure all potential users of Merge PACS and Merge OrthoPACS have received this notice. Questions regarding the recall notice can be directed to Merge Customer Support at 877-741-5369.

Recall details

Recall number
Z-2063-2019
Status
Terminated
Initiated by the company
Jul 11, 2019
Recalling firm
Merge Healthcare, Inc.
Quantity
73 devices
Product code
LLZ
FDA submissions
K173475
Distribution
Nationwide distribution to Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Wisconsin. International distribution to Belgium and Canada.

Product description

Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1

Code information (models, lots, serial numbers)

Version 7.3 (UDI Number (01)00842000100706(10)7.3.0.158618(11)180409); 7.3.1 (UDI Number (01)00842000100706(10)7.3.1.161404(11)180830); 8.0 (UDI Number (01)00842000100775(10)8.0.0.162051(11)181026); 8.0.1 (UDI Number (01)00842000100775(10)8.0.1.165704(11)190528)

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 83300).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page