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Terminated

GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

FDA Recall Z-2241-2012 · Posted 2012-08-22

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeOXO
Date Initiated2010-04-26
Date Terminated2012-08-22
Product Quantity845 units

Reason for Recall

GE OEC recalled certain 9800 Fluoroscope & 9900 Elite Models because the Snubber Board did not conform to the IEC 60601-1 standard for clearance and creepage of voltage isolation.

Firm Action

No customer communication took place. On April 26, 2010, GE began opening service cases for field engineers to begin replacing the snubber boards. This action has been completed as of October 29, 2010.

Root Cause

Component change control

Distribution Pattern

Worldwide and Nationwide (USA) 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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