FDA Device recall Z-2038-2012

OEC 9800

FDA Device
Class I
terminated
Published 2012-08-01

On 2012-08-01 the FDA classified a Class I recall of OEC 9800 by Ge Oec Medical Systems, citing please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The vertical lift co….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2038-2012
Classification	Class I
Status	terminated
Initiated	2008-02-22
Published	2012-08-01
Last updated	2026-09-13 11:53 UTC
Company	Ge Oec Medical Systems
Distribution	n/a

Product

OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

Reason

Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The vertical lift column power supply in the mainframe C-arm of the device is defective and subject to early life failure.

Identifiers

code_info	8S-1663 , 8S-2887 , 89-3119 , 89-0098 , 8S-0152-C , 89-0540 , 82-1252, 82-1519, 89-2326 , 89-1204 , 89-3272, 89… 8S-1663 , 8S-2887 , 89-3119 , 89-0098 , 8S-0152-C , 89-0540 , 82-1252, 82-1519, 89-2326 , 89-1204 , 89-3272, 89-3273 , 8S-0258 , 82-0678, 82-1884 , 8S-2321 , 82-2042 , 82-3210 , 8S-0533 , 8S-1077 , 89-0910 , 82-0139, 82-3871, 89-1757 , 89-3298 , 89-3026 , 8S-2299, 8S-2857 , 89-2043 , 89-2533 , 89-2463 , 82-0356-RC , 8S-2120 , 89-1896 , 8S-7152-MH , 8S-7190-MH , 8S-3246 , 8S-0289 , 89-1626 , 8S-0625 , 8S-1301 , 8S-1920 , 89-1025 , 8S-1838 , 8S-1367 , 8S-1627 , 89-1112 , 8S-0076-RC , 8S-0508, 8S-1946 , 8S-3073, 8S-3105 , 8S-2324-C , 8S-0073 , 8S-0180 , 8S-2237 , 82-0126, 82-3040, 82-3710 , 8S-2647 , 89-2319 , 89-3105 , 82-2560, 89-0285, 8S-1310 , 8S-2124 , 8S-1626 , 89-1486 , 82-3426 , 82-0875 , 8S-2566 , 89-0955 , 82-1801 , 82-1568 , 82-3682 , 89-0073, 89-1118, 89-1147 , 8S-0706 , 8S-0622, 8S-0772 , 8S-1139 , 8S-2182, 8S-2183 , 8S-2184 , 8S-0567 , 8S-1974 , 89-0454, 82-1606, 82-1870, 82-2533, 82-7080-MH, 89-0039, 89-1607, 89-21

code_info

8S-1663 , 8S-2887 , 89-3119 , 89-0098 , 8S-0152-C , 89-0540 , 82-1252, 82-1519, 89-2326 , 89-1204 , 89-3272, 89…

8S-1663 , 8S-2887 , 89-3119 , 89-0098 , 8S-0152-C , 89-0540 , 82-1252, 82-1519, 89-2326 , 89-1204 , 89-3272, 89-3273 , 8S-0258 , 82-0678, 82-1884 , 8S-2321 , 82-2042 , 82-3210 , 8S-0533 , 8S-1077 , 89-0910 , 82-0139, 82-3871, 89-1757 , 89-3298 , 89-3026 , 8S-2299, 8S-2857 , 89-2043 , 89-2533 , 89-2463 , 82-0356-RC , 8S-2120 , 89-1896 , 8S-7152-MH , 8S-7190-MH , 8S-3246 , 8S-0289 , 89-1626 , 8S-0625 , 8S-1301 , 8S-1920 , 89-1025 , 8S-1838 , 8S-1367 , 8S-1627 , 89-1112 , 8S-0076-RC , 8S-0508, 8S-1946 , 8S-3073, 8S-3105 , 8S-2324-C , 8S-0073 , 8S-0180 , 8S-2237 , 82-0126, 82-3040, 82-3710 , 8S-2647 , 89-2319 , 89-3105 , 82-2560, 89-0285, 8S-1310 , 8S-2124 , 8S-1626 , 89-1486 , 82-3426 , 82-0875 , 8S-2566 , 89-0955 , 82-1801 , 82-1568 , 82-3682 , 89-0073, 89-1118, 89-1147 , 8S-0706 , 8S-0622, 8S-0772 , 8S-1139 , 8S-2182, 8S-2183 , 8S-2184 , 8S-0567 , 8S-1974 , 89-0454, 82-1606, 82-1870, 82-2533, 82-7080-MH, 89-0039, 89-1607, 89-21

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2038-2012%22

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