Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0599-2017 — Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.

U.S. FDA — Device Enforcement · United States · 2016-03-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0599-2017
Date of alert: 2016-03-28
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Merge Healthcare, Inc.
Product category: device
Product type: Devices

Reported risk: The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0599-2017 — Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.

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