—#140153

Product

PET Discovery LS

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K040172
Affected lot / code info: 00000336259CN7 82445150008 00000357522CN2 RADNETPT608 00000316259CN1 210351MSDLS 00000293036CN0 352597PET 00000843236YM1 607766DLSPET 00000003458PT7 337407DLS

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-07-17
Posted by FDA: 2015-09-21
Terminated: 2016-03-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140153. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.