FDA Device Recall Z-0024-2014: GE Healthcare, LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0024-2014.

Recall Res Number

Z-0024-2014

Recalling Firm / Manufacturer

GE Healthcare, LLC

FEI Number

2126677

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2013-03-26

Date Posted

2013-10-17

Date Terminated

2013-12-05

Product Code

KPS

Event Number

65958

Product Quantity

28 (4 US & 24OUS)

Product Description GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.

Reason for Recall GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID

Action Details Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated March 26, 2013. The letter was addressed to Director of Radiology, Emergency Medicine Physicians and Radiologic Technologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information.

Distribution Pattern Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, IA, IS, LA, MA, MO, NH, NM, NY, OH, OK PA, SC, TX, UT, VA, WA, and WI, and the countries of UNITED KINGDOM, DENMARK, CHILE, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, CANADA, CZECH REPUBLIC, ECUADOR, EGYPT, ETHIOPIA, FINLAND, FRANCE, FRANCE GUIANA, GERMANY, GUADELOUPE, GUATEMALA, GUYANA, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, JORDAN, KAZAHSTAN, KOREA, KUWAIT, LATVIA, MYANMA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, POLAND, ROMANIA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, UZBEKISTAN, and VIETNAM.

Code Information / Serial Numbers MfgLotorSerial# 00000428413CN9 00000429077CN1 00000429247CN0 00000430152CN9 00000430656CN9 00000430999CN3 00000431369CN8 00000429701CN6 00000430064CN6 00000431187CN4 00000429354CN4 00000431447CN2 00000293950HM2 00000429821CN2 00000429946CN7 00000430001CN8 00000293950HM2 00000430632CN0 Shipped Shipped Shipped 00000429572CN1 00000428755CN3 00000428755CN3 00000428868CN4 00000293949HM4 00000428536CN7 00000429820CN4

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Medical Device Recall: Z-0024-2014

Recall Parameters & Description

Related Establishments / Registrations

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