PET Discovery ST 16
- Company
- Ge Healthcare
- Recall Initiated
- July 17, 2015
- Posted
- September 21, 2015
- Terminated
- March 8, 2016
- Recall Number
- Z-2803-2015
- Quantity
- 18
- 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
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
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