Food, drugs, devices › GE Healthcare, LLC
Device recall: GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use
GE Healthcare, LLC (Waukesha, WI) initiated this device recall on 19 Jun 2013; FDA lists 1 product record under event 66168, 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. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 25 Oct 2013. Initiation: voluntary: firm initiated. GE Healthcare, LLC has 225 enforcement events on this register, with a median of 1 product record 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 Healthcare, LLC, Waukesha, WI.
Reason for recall
"GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging Systems. A patient data management error may prevent the Discovery IGS 730 Imaging System from booting on start-up or re-booting during procedure. The boot issue may occur when a large amount of patient data remains in the browser and is not deleted. The inability to boot the system ma"
Distribution
"Worldwide distribution: US (nationwide) including states of : PA and TN; countries of: FRANCE and SINGAPORE."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2253-2013 | GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the… | 4 (2 US, 2 OUS) | Class II | Terminated | 25 Sep 2013 |
Context
Other enforcement events for GE Healthcare, LLC
All 225 events for GE Healthcare, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging Systems. A patient data management error may prevent the Discovery IGS 730 Imaging System from booting on start-up or re-booting during procedure. The boot issue may occur when a large amount of patient data remains in the browser and is not deleted. The inability to boot the system ma"
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 states of : PA and TN; countries of: FRANCE and SINGAPORE."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 25 Oct 2013. "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.