GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use

FDA device recall Z-2253-2013 · posted 2013-09-18 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

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

Action taken

The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 19, 2013 to its Consignees/customers. The letter described the Safety Issue, Safely Instructions, Affected Product Detail, Product Correction and Contact Information. The consignees were instructed to please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. GE Healthcare will correct all affected systems at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please call : United States: 800 437 1171. For other countries, please contact your local GE Healthcare Service Representative.

Root cause

Software design

Status

Terminated

Product code

OWB

Quantity affected

4 (2 US, 2 OUS)

Distribution

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

Date initiated

2013-06-19

Date posted

2013-09-18

Date terminated

2013-10-25

Location

Waukesha, WI

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