Recall Z-2301-2016— Merge Healthcare, Inc.
Class II · Terminated
Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2016-01-30, terminated 2019-04-08. It names one FDA 510(k) clearance: K082144. Product: Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.. Reason: Studies coming over via telmed were missing patient's DOB, procedure, and referring physician..
- Recalling firm
- Merge Healthcare, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-30
- Terminated
- 2019-04-08
- 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 PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Reason for recall
Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.
Data sourced from openFDA. This site is unofficial and independent of the FDA.