FDA Device recall Z-2040-2012

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

• FDA Device
• Class I
• terminated
• Published 2012-08-01

On 2012-08-01 the FDA classified a Class I recall of OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures by Ge Oec Medical Systems, citing 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 Minivie….

Read the official FDA Device notice

Product

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

Reason

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

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2040-2012%22

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