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

Recall Z-0748-2014 — Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different acquisition devices, including digital mammography, ultrasound, MRI and CT. Two and three dimens

U.S. FDA — Device Enforcement · United States · 2013-08-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0748-2014
Date of alert: 2013-08-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Healthcare It
Product category: device
Product type: Devices

Reported risk: There is a potential safety issue with the 8.0.2 version software of the Merge (Cedara) Mammo viewer. The Merge Mammo viewer can load and display images not in synch with the selected or highlighted images in the thumbnail navigator. This incorrect image display issue could result in an inaccurate reading on the Merge Mammo workstation. This could result in a missed intervention or mis-diagnosis.

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.

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