Reported Aug 29, 2012 · Terminated

GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused…

GE OEC Medical Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE OEC Medical Systems, Inc · 384 Wright Brothers Dr · Salt Lake City, UT · 84116-2862

Is this the product you have?

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.

Lot codes and dates: Serial numbers
793 of 793 codes
69-0128
82-0157
82-0158
82-0185
82-0191
82-0210
82-0215
82-0223
82-0229
82-0266
82-0324
82-0328
82-0464
82-0477
82-0484
82-0505-RC
82-0507
82-0542
82-0544
82-0546
82-0551
82-0604
82-0648
82-0673
82-0680
82-0714
82-0733
82-0779
82-0858
82-0869
82-0884
82-0906
82-0918
82-0965
82-1004
82-1009
82-1057-RC
82-1070
82-1139
82-1191
82-1194
82-1225
82-1247
82-1303
82-1405
82-1434
82-1458
82-1480
82-1534
82-1547-RC
82-1564
82-1585
82-1588
82-1601
82-1604
82-1621
82-1694
82-1695
82-1699
82-1797
Amount recalled: 845 units

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new GE OEC Medical Systems, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.

By hazard

Medical device recalls

Other recalls from GE OEC Medical Systems, Inc.

OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile… Dec 25, 2024
OEC Flexiview 8800 Systems with 9-inch Image Intensifier Aug 9, 2023
OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage… Aug 4, 2021
OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems Mar 22, 2017
OEC 9800. MDL Numbers: D222250, D141598 Feb 1, 2017
OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide… Jan 18, 2017

20 in total.

All recall categories · Browse the whole archive