PET Discovery LS
- Company
- Ge Healthcare
- Recall Initiated
- July 17, 2015
- Posted
- September 21, 2015
- Terminated
- March 8, 2016
- Recall Number
- Z-2802-2015
- Quantity
- 6
- Firm Location
- Waukesha, WI
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.
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.
Lot / Code Info
00000336259CN7 82445150008 00000357522CN2 RADNETPT608 00000316259CN1 210351MSDLS 00000293036CN0 352597PET 00000843236YM1 607766DLSPET 00000003458PT7 337407DLS
Root Cause
Process control
Action Taken
GE Healthcare sent an "Urgent Medical Device Correction" letter to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. Ref# 25463