Reported Jul 4, 2012 · Terminated

OEC Uroview 2800, Model number A349855. 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?

OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.

Lot codes and dates: All Serial Numbers
640 of 640 codes
P4-0004-L
P4-0005-L
P4-0006-R-RC1
P4-0008-R
P4-0011-L
P6-0654-R
P4-0012-R
P4-0013-L
P4-0014-L
P4-0015-L
P4-0016-L
P4-0017-L
P4-0018-L
P4-0019-R
P4-0020-L
P4-0021-L
P4-0022-R
P4-0023-L
P4-0024-R
P4-0025-R
P4-0026-L
P4-0027-R
P4-0028-R
P4-0029-R
P4-0030-R
P4-0031-L
P4-0680-L
P4-0032-R
P4-0033-R
P4-0034-R
P4-0035-R
P4-0036-R
P4-0037-R
P4-0038-L
P4-0039-R
P4-0042-R
P4-0044-L
P4-0045-R
P4-0046-L
P4-0047-L-RC
P4-0048-L
P4-0049-R
P4-0050-L
P4-0051-L
P4-0052-R
P4-0053-L
P4-0054-R
P4-0074-R
P4-0055-L
P4-0058-R
P4-0059-L
P4-0062-L
P4-0064-L
P4-0067-L
P4-0075-L
P4-0068-R
P4-0070-L
P4-0071-L
P4-0073-R
P4-0076-R
Amount recalled: 717 units

Why it was recalled

Recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mode" and "digital spot mode", and the system does not reboot.

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

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