PlainRecalls
FDA Devices Moderate Class II Terminated

GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy.

Reported: June 1, 2016 Initiated: April 15, 2016 #Z-1707-2016

Product Description

GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy.

Reason for Recall

Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure.

Details

Recalling Firm
GE Medical Systems, LLC
Units Affected
25
Distribution
Worldwide Distribution-US (nationwide) including the states of AL, CA, CO, CT, IL, IN, MD, MN, MS, MO, NE,NV,NH, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI, and the countries of ALGERIA, BELGIUM CANADA, CHINA, FRANCE, GERMANY, HUNGARY, IRELAND, ITALY, JAPAN, MEXICO, NETHERLANDS, PERU, SAUDI ARABIA, SINGAPORE, UNITED ARAB EMIRATES, and UNITED KINGDOM.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy.. Recalled by GE Medical Systems, LLC. Units affected: 25.
Why was this product recalled?
Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 1, 2016. Severity: Moderate. Recall number: Z-1707-2016.