Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for…

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• Merge PACS software
• Product UsageMerge 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

Lot codes and dates

• Versions
  • V6.0 MR2
  • 6.0 MR3
  • 6.0 MR3 CU
  • 6.0 MR4
  • 6.0 MR4 CU1
  • 6.0 MR4 CU2
  • 6.0 MR4 CU3
  • 6.0 MR4 CU4
  • 6.0 MR4 CU5
  • 6.0 MR4 CU6
  • 6.0 MR4
  • CU7
  • 6.0 MR4 CU8
  • 6.0 MR4 CU9
  • 6.0 MR4 CU10
  • 6.0 MR4 CU11
  • 6.1
  • 6.1.1
  • 6.1.2
  • 6.1.3
  • 6.2
  • 6.2.1
  • 6.2.2
  • 6.2.3
  • 6.2.4
  • 6.2.5
  • 6.3
  • 6.4
  • 6.4.1
  • 6.4.2
  • 6.4.3
  • 6.4.4
  • 6.4.5
  • 6.4.6
  • 6.4.7
  • 6.5
  • 6.5.5
  • 6.5.6
  • 6.5.7
  • 6.5.8
  • 6.5.9
  • 6.6
  • 6.6.1
  • 6.6.1.1
  • 6.6.2
  • 6.6.2.1
  • 6.6.2.2
  • 7.0
  • 7.0.1
  • and 7.0.2

Amount recalled

534 sites potentially have the affected versions

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

• Merge LIS software.
• iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.

Where it was sold

• Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.