The Recall Desk
ModerateFDA (Devices)·Z-2159-2016·Announced 2016-07-20

Merge OfficePACS Software Recalled for Potential Data Loss

Merge Healthcare is recalling OfficePACS software version 3.4 because archiving failures may cause data loss at 49 medical facilities.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is potential data loss, which is a significant operational risk but does not involve direct physical injury or death, fitting the Moderate category for non-physical hazards without reported harm.

Plain-English summary

Merge Healthcare, Inc. is recalling Merge OfficePACS software, version 3.4. The recall is due to a defect where the product archiving function does not work properly, which can result in potential data loss.

The affected software was distributed to 49 medical facilities located in Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Massachusetts, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Oklahoma, Pennsylvania, South Carolina, Tennessee, Virginia, and Washington. There was no distribution to government, military, or foreign entities.

Healthcare facilities using this software should contact Merge Healthcare for instructions on how to resolve the archiving issue and prevent data loss.

The recalled product

Product
Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
Hazard
Affected units
49

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Version 3.4

Distribution