OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional proce

FDA device recall Z-2040-2012 · posted 2012-07-24 · 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. The OEC 6800 Miniview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lock-up, incorrect image display, incorrect dose area calculated air kerma in "film mo

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. On 11/20/2006, two written notifications were sent to 1513 identified consignees, addressed to the Facility Administrator and the Radiology Administrator for a combined total of 3026 letters. The Urgent Recall Notice, dated 11/8/2006, advised customers that GE Healthcare had identified several intermittent potential safety issues that may occur with the identified affected product. The notification also provided interim or permanent solutions for each of the problems described. For the issues that did not have permanent solutions at the time, the firm was to contact customers and remedy the issues free of charge. For the issues that did have a permanent fix at the time, the GEHC OEC service team was to contact customers to install the correction. If customers had questions or concerns, they were to contact the service team for further information at 800-874-7378 option 8. On 04/23, 2007, a second written notification was sent via certified mail to the same 1513 consignees providing further clarification on the issue of "incorrect Image Display" and a temporary remedy to the issue.

Root cause

Device Design

Status

Terminated

Product code

OXO

Quantity affected

1,933 units

Distribution

Worldwide Distribution

Date initiated

2006-11-20

Date posted

2012-07-24

Date terminated

2013-05-13

Location

Salt Lake City, UT

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