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Recall Observatory FDA recall evidence

Device product

RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.

Z-2627-2016

January 31, 2016

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 74919
Status
Terminated
Classification
Class II
Quantity
25 sites potentially have the affected versions
Official record key
device-enforcement:Z-2627-2016

Official wording

Reason: Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than the first viewport.

Code information: Versions: 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E, SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, and 5.35.4 HF0513

Distribution pattern: Distribution was made to AL, AZ, CA, IL, MD, MA, MI, MO, NV, NJ, NC, OH, PA, TN, and VA. Government distribution was made to OK. There was no foreign/military distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than the first viewport.