—#132213

Product

GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular & non vascular diagnostic and interventional procedures. Discovery IGS 740: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and nonvascular, diagnostic and interventional procedures.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K113403, K133278
Affected lot / code info: Mfg Lot or Serial # System ID 0000013C2A0001 203694IGS730 0000011C2A0005 610954OR1 0000014A2A0009 718283D740 0000014A2A0007 SO4208228 0000014A2A0016 SO4242294 0000014A2A0004 206VMDISCOVERY1 Not available 330375HOR 0000014A2A0006 190020RX26 Not available 190059RX30 Not available SO4165355 Not available 82416120043 Not available 82416040061 00000011C2A003 A4185526 0000012C2A0002 M4160476 0000014A2A0008 S41600101 00000612802BU9 M54866AG1 Not available M40480222 Not available HC4348XR11 0000014A2A0001 YV2000 Not available XR649425BU6 Not available SO4239583 Not available AE1477RX04 0000013A2A0003 00169VAS01 0000013A2A0002 10692VAS01

Why it was recalled

Potential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products.

Root cause (FDA determination)

Software design

Action the firm took

Consignees were sent a 12/10/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 12223 dated December 10, 2014. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information ( US call 800-437-1171, other countries contact your local GE Healthcare Service Representative).

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-Distributed in the states of CO, CT, MS, NJ, NY, OH, and WA, and the countries of BELGIUM, CANADA, CHINA, FRANCE, GERMANY, JAPAN, MEXICO, PERU, UNITED ARAB EMIRATES, and UNITED KINGDOM.

Timeline

Recall initiated: 2014-12-10
Posted by FDA: 2015-01-14
Terminated: 2015-06-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132213. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.