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
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
Merge PACS
Lot or serial number
8.0.1
Model or catalog number
MERGE PACS
Companies
- Manufacturer
-
Merge Healthcare Incorporated,
900 Walnut Ridge Drive,
Hartland
53029
Wisconsin
UNITED STATES