Reported Nov 19, 2014 · Terminated

Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during…

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?

Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgical and interventional procedures.

Lot codes and dates: Serial No
311 of 311 codes
82-0013
82-0045
82-0061
82-0071
82-0085
82-0122
82-0133
82-0190
82-0246
82-0357
82-0528
82-0533
82-0597
82-0626
82-0699
82-0702
82-0707
82-0718
82-0805
82-0818
82-0854
82-0855
82-0946
82-1040
82-1052
82-1062
82-1106
82-1133
82-1199
82-1292
82-1324
82-1348
82-1411
82-1453
82-1460
82-1526
82-1542
82-1608
82-1651
82-1658
82-1679
82-1709
82-1731
82-1773
82-1822
82-1867
82-1882
82-1905
82-1914
82-1979
82-2017
82-2018
82-2024
82-2030
82-2036
82-2049
82-2165
82-2169
82-2206
82-2225
Amount recalled: 311

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Why it was recalled

GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.

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

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

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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