XELERIS (1.0, 1.1, 2.0 & 2.1) PROCESSING AND REVIEW WORKSTATION The display, processing, archiving, and communication of

FDA device recall Z-0537-2011 · posted 2010-12-03 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

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

Action taken

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

Status

Terminated

Product code

LLZ

Quantity affected

6020

Distribution

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

Date initiated

2010-10-27

Date posted

2010-12-03

Date terminated

2012-08-28

Location

Waukesha, WI

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