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Terminated

GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01.

FDA Recall Z-2262-2012 · Posted 2012-08-23

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeOXO
Date Initiated2008-10-10
Date Terminated2013-01-10
Product Quantity149 units

Reason for Recall

GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye.

Firm Action

An Urgent Safety Advisory Notice was sent to consignees on October 10, 2008. The letter identified the affected product and notified customers of the situation, along with instructing them to discontinue use until proper validation and instruction update for cable use was completed. GEHC OEC was to have contacted customers when the solution became available and resolved it at no cost to the customer.

Root Cause

Device Design

Distribution Pattern

Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041932OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEMGe Oec Medical Systems, Inc. · 2004-08-18K024012OEC 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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