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Terminated

XELERIS (1.0, 1.1, 2.0 & 2.1) PROCESSING AND 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.

FDA Recall Z-0537-2011 · Posted 2010-12-03

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLLZ
Date Initiated2010-10-27
Date Terminated2012-08-28
Product Quantity6020

Reason for Recall

GE Healthcare has become aware of inaccurate user protocol setup associated with the Thyroid Uptake Index application on certain Xeleris workstations(1.0, 1.1, 2.0, 2.1) that may impact patient safety. Inaccurate protocol setup by the user while using Thyroid Uptake Index application has been identified on certain Xeleris workstations. Incorrect protocol setup during clinical data acquisition a

Firm Action

GE Healthcare sent an "Urgent Medical Device Correction" letter dated October 27, 2010, to all consignees. The letter was addressed to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology and Radiologists/Cardiologists and Identifed the product, the problem and the action to be taken by the consignees. Consignees were instructed to replace the original protocol instructions provided with their system with the updated protocol instructions provided with the letter. For any questions consignees were to contact their local GE Healthcare Service Representative or contact the GE Healthcare Call Center: United States or Canada (800) 437-1171 Other countries: (262) 896-2890

Root Cause

Other

Distribution Pattern

All States in continental USA including DC and PR. Viet Nam, Venezuela, Uruguay, United Kingdom, Ukraine, Turkey, Thailand, Taiwan, Switzerland, Sweden, Spain, South Africa, Slovakia, Singapore, Saudi Arabia, Russian Federation, Republic of Korea, Portugal, Poland, Philippines, Panama, Pakistan, Norway, New Zealand, Netherlands, Morocco, Mexico, Martinique, Malaysia, Luxembourg, Kuwait, Kenya, Japan, Jamaica, Italy, Israel, Ireland, Indonesia, India, Hungary, Hong Kong, Guadeloupe, Greece, Germany, France, Finland, Ecuador, Dominican Republic, Cyprus, Colombia, China, Canada, Bulgaria, Brazil, Bosnia & Herzegovina, Belgium, Azerbaijan, Austria, Australia, Argentina, Algeria.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051673XELERIS 2 PROCESSING AND REVIEW WORKSTATIONGE Medical Systems · 2005-07-18K024137JUPITER PROCESSING AND REVIEW WORKSTATIONGe Medical Systems, Inc. · 2003-01-15

Official Source

View FDA Recall →

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

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