—#140154

Product

PET Discovery ST 16

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K041543
Affected lot / code info: 00000407058CN7 B5127901 00000393804CN0 YE0524 00000007118PT3 A098PE01 00000005880PT0 853450026 00000295121CN8 469525DLS 00000331760CN9 256327PET 00000305946CN6 201599DST 00000314955CN6 RADNETPT1813 00000362166CN1 203694DST16 00000354677CN7 918744PETCT 00000359856CN2 713704DST 00000364001CN8 845454PCT 00000299430CN9 817927DST 00000011079PT1 662232DST 00000005835PT4 256705PS2 00000010481PT0 615320DST 00000005903PT0 856794DISCST 00000412917CN7 818DCCDST

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 #140154. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.