Device recall: RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to…
Class II FDA enforcement event 74924. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Merge Healthcare, Inc. started this device recall on 30 Jan 2016. The firm address in the FDA record is in Hartland, WI. FDA put the recall in Class II. FDA event 74924 has 2 product records. The first FDA enforcement report date is 7 Sep 2016. The record gives the status Terminated, with the termination date 15 Oct 2019.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Distribution to: CO and OK.
Recalling firm
Merge Healthcare, Inc., Hartland, WI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2685-2016 | RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format. | 96 sites potentially have the affected versions for both products | Class II | Terminated | 7 Sep 2016 |
| Z-2686-2016 | iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data. | 96 sites potentially have the affected versions for both products | Class II | Terminated | 7 Sep 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 84
Other events of the firm
Official channels
- FDA enforcement report Z-2685-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 74924. https://recallregister.com/fda/ii/74924/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Distribution to: CO and OK.
- What quantity of product is in FDA event 74924?
- The event has 2 product records. The first record gives this quantity:
96 sites potentially have the affected versions for both products
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.