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Recall Observatory FDA recall evidence

Device product

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 angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image guided surgical procedures. The OR table is suitable for interventional and surgical procedures.

Z-2253-2013

June 19, 2013

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 66168
Status
Terminated
Classification
Class II
Quantity
4 (2 US, 2 OUS)
Official record key
device-enforcement:Z-2253-2013

Official wording

Reason: 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

Code information: Mfg Lot or Serial # 00000611882BU2 00000612803BU7 00000613979BU4 00000620447BU3

Distribution pattern: Worldwide distribution: US (nationwide) including states of : PA and TN; countries of: FRANCE and SINGAPORE.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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