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Terminated

PET Discovery ST 16

FDA Recall Z-2803-2015 · Posted 2015-09-21

Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeKPS
Date Initiated2015-07-17
Date Terminated2016-03-08
Product Quantity18

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.

Firm Action

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

Root Cause

Process control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041543GE DISCOVERY STGE Healthcare · 2004-06-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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