Recall Z-2796-2016— Merge Healthcare, Inc.
Class II · Terminated
Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2013-05-06, terminated 2019-07-26. It names one FDA 510(k) clearance: K053281. Product: RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.. Reason: Multiple studies were missing at a customer location that never made it to the archive before watermarking.
- Recalling firm
- Merge Healthcare, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-06
- Terminated
- 2019-07-26
- 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
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason for recall
Multiple studies were missing at a customer location that never made it to the archive before watermarking
Data sourced from openFDA. This site is unofficial and independent of the FDA.