Merge PACS (2019-07-23)

Starting date:

July 23, 2019

Posting date:

August 9, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70657

Last updated: 2019-08-09

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  Reason
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  Affected products

Affected Products

Merge PACS

Reason

Merge Healthcare identified issues that may occur on Merge PACS and Merge ORTHOPACS Software Version 8.0.X. Two are possible safety issues: 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. One is a non-hazardous failure to meet a claim related to window/level display settings. Merge became aware on 16 july 2019 that version 8.0.X was distributed in Canada.

Affected products