OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide t

FDA device recall Z-2126-2012 · posted 2012-08-01 · 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. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and

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 Notices dated October 11, 2006 and February 21, 2007 via certified mail delivery letter to affected customers. The notices identified the affected products, problem and actions to be taken. Customers were informed that a GEHC OEC field service engineer would be contacting their facility to arrange to have a replacement hard disk drive installed on the affected system(s). Customers were instructed to ensure that images on the hard disk drive were stored via an alternate permanent media as the hard disk drive approaches the 170 image capacity until a GEHC OEC field service engineer had replaced the drive. For questions regardiug this issues contact the service team at 800-874-7378.

Root cause

Software design

Status

Terminated

Product code

IZL

Quantity affected

Part of a total of 82 units distributed.

Distribution

Worldwide Distribution - US (nationwide) and the countries of: Canada, France, Japan, and China.

Date initiated

2007-03-27

Date posted

2012-08-01

Date terminated

2012-08-02

Location

Salt Lake City, UT

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