—#121602

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.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K113403
Affected lot / code info: Mfg Lot or Serial # 00000611882BU2 00000612803BU7 00000613979BU4 00000620447BU3

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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

Timeline

Recall initiated: 2013-06-19
Posted by FDA: 2013-09-18
Terminated: 2013-10-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121602. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.