InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product

FDA device recall Z-1985-2012 · posted 2012-07-12 · Terminated

Recall details

Recalling firm

GE OEC Medical Systems, Inc

Reason for recall

Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. On October 11, 2006, GE Healthcare recalled GE OEC InstaTrak 3500 Plus System with Software version 5.2, the surgical Navigation and Visualization Application due to software related issues.

Action taken

Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC sent an Urgent Safety Advisory Notice dated October 11, 2006 to all affected customers. The notice identified the affected product, problem and actions to be taken. Customers were informed that a GEHC OEC would be contacting their facility to verify the current software version installed at their site. If the issue affects their facility a software upgradewill be provided at no cost. Customers were advised to excercise caution when using the affected product until the 5.2.1software upgrade is completed. For question contact GE Healthcare Customer Service at 1-800-874-7378, option 1 or 1-801-536-4688, option 1. For questions regarding this recall call 801-536-4516.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

86 units

Distribution

Worldwide Distribution - US (nationwide)

Date initiated

2006-09-15

Date posted

2012-07-12

Date terminated

2012-08-21

Location

Salt Lake City, UT

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