Food, drugs, devices › GE Medical Systems, LLC
Device recall: GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
GE Medical Systems, LLC (Waukesha, WI) initiated this device recall on 15 Apr 2016; FDA lists 2 product records under event 73968, classified Class II.
FDA defines Class II as 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. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 22 Nov 2016. Initiation: voluntary: firm initiated. GE Medical Systems, LLC has 42 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GE Medical Systems, LLC, Waukesha, WI.
Reason for recall
"Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure."
Distribution
"Worldwide Distribution-US (nationwide) including the states of AL, CA, CO, CT, IL, IN, MD, MN, MS, MO, NE,NV,NH, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI, and the countries of ALGERIA,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1706-2016 | GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy. | 54 | Class II | Terminated | 1 Jun 2016 |
| Z-1707-2016 | GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy. | 25 | Class II | Terminated | 1 Jun 2016 |
Context
Other enforcement events for GE Medical Systems, LLC
All 42 events for GE Medical Systems, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution-US (nationwide) including the states of AL, CA, CO, CT, IL, IN, MD, MN, MS, MO, NE,NV,NH, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI, and the countries of ALGERIA,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 22 Nov 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.