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FDA (Device enforcement)Recalled 2015-07-17closedclass ii

GE Healthcare: PET Discovery LS

Is my product affected?

PET Discovery LS

  • UPC 82445150008

Check against the official notice below — it lists the full affected range.

What happened

GE Healthcare has recalled six PET Discovery LS, Discovery ST PET CT, and Lightspeed CT scanners worldwide due to a potential hazard where the power supply could be expelled from the device. The affected units have been distributed throughout the United States and to Argentina, Australia, Austria, Belgium, Canada, China, Denmark, Estonia, Finland, France, Germany, Hungary, India, Indonesia, Israel, Italy, Japan, Republic of Korea, Mexico, Norway, Poland, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.

The specific scanners involved in this recall are identified by their lot and code information. The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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. Quantity: 6 Lot/code info: 00000336259CN7 82445150008 00000357522CN2 RADNETPT608 00000316259CN1 210351MSDLS 00000293036CN0 352597PET 00000843236YM1 607766DLSPET 00000003458PT7 337407DLS

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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