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U.S. Department of Health and Human Services

Class 2 Device Recall Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0

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 Class 2 Recall
Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0
see related information
Date Posted February 15, 2011
Recall Status1 Terminated on October 16, 2012
Recall Number Z-1250-2011
Recall Event ID 57159
Premarket Notification
510(K) Numbers
K024137  K051673  K093982 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0 The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration. 3X The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing , archiving, printing, reporting and networking of NM data including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomnographic scans (SPECT, Gated SPECT, dedicated PET or Camera-Based-PET) acquired by gammna cameras or PET scanners. The system can run on dedicated workstation or in a server-client configuration. The NM or PET data can be coupled with registered and/or fused CT or MR scans and with physiological signals, in order to: depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes..
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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
GE Healthcare has become aware of safety issues relevant for the Xeleris Workstation 1.0, 1.1, 2.0, 2.1, 3.0: 1. Measurements taken on the CT Images on the CT system are different from the Xeleris Workstation 2. Inaccurate PET SUV values may be calculated when data is retrieved from PACS after being processed in the Xeleris. 3. Wrong marking of Early and Late result series on display in Bra
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated January 12, 2011 to all consignees/customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to please ensure that all potential users in their facility are made aware of this safety notification and the recommended actions. A GE Healthcare Service representative will perform the required software update on each affected system. If you have any questions or concerns regarding this notification, contact your local GE Healthcare Service Representative. You may also contact GE Healthcare call center in US or Canada at 800-437-1171 and other countries at 262-896-2890.
Quantity in Commerce 6046
Distribution Worldwide distribution: USA including DC, PR, and Guam; and countries including: AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA, AZERBAIJAN, BELGIUM, BOSNIA & HERZEGOVIA, BULGARIA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KENYA, KUWAIT, LUXEMBOURG, LEBANON, MALY ASIA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, PORTUGAL POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SPAIN, SOUTH AFRICA, SOUTH KOREA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, and VIET NAM.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS
510(K)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS F.I. HAIFA
510(K)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS, INC.
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