Device recall: GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is indicated for use in…
Class II FDA enforcement event 65022. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems.
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
GE Healthcare, LLC started this device recall on 16 May 2011. The firm address in the FDA record is in Waukesha, WI. FDA put the recall in Class II. FDA event 65022 has 1 product record. The first FDA enforcement report date is 10 Jul 2013. The record gives the status Terminated, with the termination date 13 Mar 2014.
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.
Worldwide distribution - USA including AZ, CA, CO, FL, ID, IL, ME, NV,NY, NC, OK, TN, UT, and WI; and Internationally to Canada, Chile, France, Germany, Italy, Japan, Korea, Norway and Spain.
Recalling firm
GE Healthcare, LLC, Waukesha, WI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1616-2013 | GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. | 48 | Class II | Terminated | 10 Jul 2013 |
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 2011
- 114
- Share of these events in Class II
- 89%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 225
Other events of the firm
Official channels
- FDA enforcement report Z-1616-2013The 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 65022. https://recallregister.com/fda/ii/65022/. 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:
Worldwide distribution - USA including AZ, CA, CO, FL, ID, IL, ME, NV,NY, NC, OK, TN, UT, and WI; and Internationally to Canada, Chile, France, Germany, Italy, Japan, Korea, Norway and Spain.
- What quantity of product is in FDA event 65022?
- The FDA record gives this quantity:
48
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2011 have the same class?
- 89% of the 114 device events that started in 2011 are in Class II.