Recall Z-1180-2017— Merge Healthcare, Inc.
Class II · Terminated
Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2015-11-17, terminated 2017-02-10. It names one FDA 510(k) clearance: K053281. Product: Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.. Reason: The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment..
- Recalling firm
- Merge Healthcare, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-17
- 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
Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason for recall
The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.
Data sourced from openFDA. This site is unofficial and independent of the FDA.