Recall Z-2627-2016— Merge Healthcare, Inc.
Class II · Terminated
Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2016-01-31, terminated 2017-02-10. It names one FDA 510(k) clearance: K053281. Product: RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.. 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..
- Recalling firm
- Merge Healthcare, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-31
- Terminated
- 2017-02-10
- Firm location
- Hartland, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.