FDAClass IISeptember 30, 2015

PET Discovery ST 16 recall

PET Discovery ST 16

Why was PET Discovery ST 16 recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
PET Discovery ST 16
Recalling firm
GE Healthcare
Quantity
18
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.
Recall date
September 30, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls