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Terminated

OEC FluoroTrak Plus 9800 Fluoroscopic X-ray System,

FDA Recall Z-0557-2007 · Posted 2007-03-22

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2007-02-09
Date Terminated2007-06-26
Product Quantity11 units of all models

Reason for Recall

During routine service, a cover may have been installed without the required proper lead shielding.

Firm Action

Consignees were notified by telephone on 02/09/2007 and told to discontinue use of the units until they could be inspected by GE personnel. GE personnel visited all 8 sites on 02/12/2007.

Root Cause

Other

Distribution Pattern

Nationwide to AL, AZ, IA, OH, TX, VA, and WV.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K024012OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEMGe Oec Medical Systems · 2003-03-20K022069OEC FLUOROTRAK 9800 PLUSGe Oec Medical Systems · 2002-09-17K021049OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEMGe Oec Medical Systems · 2002-04-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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