PlainRecalls
FDA Devices Moderate Class II Terminated

Lightspeed 16 CT

Reported: September 30, 2015 Initiated: July 17, 2015 #Z-2801-2015

Product Description

Lightspeed 16 CT

Reason for Recall

Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.

Details

Recalling Firm
GE Healthcare
Units Affected
416
Distribution
Worldwide Distribution - US (nationwide) and to the countries of : ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, HUNGRY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, MEXICO, NORWAY, POLAND, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN and UNITED KINGDOM.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
Lightspeed 16 CT. Recalled by GE Healthcare. Units affected: 416.
Why was this product recalled?
Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 30, 2015. Severity: Moderate. Recall number: Z-2801-2015.