RecallRadar

FDA Device recall Z-2590-2017

Merge PACS software

On 2017-06-21 the FDA classified a Class II recall of Merge PACS software by Merge Healthcare, citing merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for vi….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2590-2017
ClassificationClass II
Statusterminated
Initiated2017-05-08
Published2017-06-21
Last updated2026-09-13 11:54 UTC
CompanyMerge Healthcare
DistributionUS

Product

Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

Reason

Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing.

Identifiers

code_infoVersions 7.0.2.1, 7.0.2.2, 7.0.2.3, 7.0.2.3 P1, and 7.0.2.3 P2

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2590-2017%22

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