Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
This recall has been terminated (originally issued July 29, 2016).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- January 30, 2016
- Posted
- July 29, 2016
- Terminated
- May 7, 2021
- Recall Number
- Z-2303-2016
- Quantity
- 208 sites have the affected versions
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
Reason for Recall
A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
Distribution
Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Jordan, New Zealand, and the United Kingdom.
Lot / Code Info
Versions: V6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9, 6.6.0, 6.6.1, 6.6.1.1, 6.6.2
Root Cause
Software design
Action Taken
The recalling firm, Merge, issued an "URGENT: MEDICAL DEVICE RECALL" letter dated 1/27/2016 via e-mail on 1/30/2016 or via certified mail if they did not have an e-mail address for the customers. The letter described the product, problem and actions to be taken. The customers were instructed to not discontinue use of Merge PACS; to open prior comparison studies in the secondary viewer to check if there were annotations and read the report or visit note pertaining to that study to see if there are noted findings that were not otherwise apparent; to receive an upgrade call Merge Customer Service at (877) 741-5369 or send an email to support@merge.com to schedule the upgrade (Reference this call #2016-010); complete the online form: http://www.merge.com/Landing-Pages/Customer-Upgrade-Decline-Form.aspx no later than 2/22/2016; If you decide to decline the maintenance release, complete the attached Customer Decline Response form and return to Merge Healthcare via recall@merge.com, and ensure all users of the product are provided with this notification. If you have further distributed this product, identify your customers and notify them at once of this product recall. If you have any additional questions, call Merge Customer Service at (877) 741-5369 or support@merge.com.