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U.S. Department of Health and Human Services

Class 2 Device Recall Xeleris 2 Processing & Review Workstation

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  Class 2 Device Recall Xeleris 2 Processing & Review Workstation see related information
Date Initiated by Firm October 06, 2011
Date Posted April 23, 2013
Recall Status1 Terminated 3 on February 04, 2014
Recall Number Z-1164-2013
Recall Event ID 64804
510(K)Number K051673  
Product Classification System, image processing, radiological - Product Code LLZ
Product GE Healthcare, Xeleris 2 Processing & Review Workstation.

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
Code Information Mfg Lot or Serial # 0000CZC7105FJM000 00000CZC827NRN000 00000CZC8283V4000 0000CZC8283V47000 0000CZC8283V72001 0000CZC8283TX5001 00000000211423001 0000CZC8161XJT000 0000CZC94154WV003 0000CZC83942HL000 0000CZC8396CC9001 
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall		 GE Healthcare has become aware of a software issue in your Xeleris 2.1 workstation (that is used for processing Discovery 530/570 data), that may impact patient safety. On imported CT scans, Myocardial Perfusion Imaging (MPI) studies may create artifacts in attenuation corrected images. This may lead to a potential for misdiagnosis.
FDA Determined
Cause 2		 Software design
Action GE Healthcare sent an Urgent Medical Device Correction letter dated October 5, 2011, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Consignees were instructed to contact their local GE Healthcare Service Representative if they have questions or concerns. They may also contact GE Healthcare Call Center , United States or Canada at 800-437-1171. Other countries 262-896-2890. For questions regarding this recall call 262-513-4122.
Quantity in Commerce 11
Distribution Worldwide Distribution - USA including GA, and NY; and countries of: Canada, Israel, Italy and Switzerland.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS
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