Recall Z-2159-2016— Merge Healthcare, Inc.
Class II · Terminated
Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2016-01-31, terminated 2017-01-26. It names one FDA 510(k) clearance: K033825. Product: Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.. Reason: Potential data loss occurs as a result of product archiving not working properly..
- Recalling firm
- Merge Healthcare, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-31
- Terminated
- 2017-01-26
- 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 OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
Reason for recall
Potential data loss occurs as a result of product archiving not working properly.
Data sourced from openFDA. This site is unofficial and independent of the FDA.