Merge PACS software. The firm name on the label is Merge… recallZ-2303-2016 · Merge Healthcare, Inc. · initiated Jan 30, 2016
Class II Terminated All recalls posted in July 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Merge Healthcare, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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 [email protected] 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 [email protected], 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 [email protected].
Recall details
- Recall number
- Z-2303-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 30, 2016
- Posted by the FDA
- Jul 29, 2016
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 208 sites have the affected versions
- Product code
- LLZ
- FDA submissions
- K082144
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Jordan, New Zealand, and the United Kingdom.
Product description
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
2 devices cleared under K082144 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Merge PACS 7.2Merge Healthcare Solutions Inc. · System, Image Processing, Radiological1 report
- Merge PACS 6.6.3.2Merge Healthcare Solutions Inc. · System, Image Processing, Radiological1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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