GE Healthcare, LLC: Medical Device Recall in 2013 - (Recall #: Z-2253-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 19, 2013

Date Posted: September 25, 2013

Recall Number: Z-2253-2013

Event ID: 66168

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

Status: Terminated

Product Quantity: 4 (2 US, 2 OUS)

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.

Voluntary or Mandated:

Voluntary: Firm initiated