Reported Aug 8, 2012 · Terminated
OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide…
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 MiniView 6800 MobileMDL number A349855
- Product UsageThe mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical, orthopedic, and extremity imaging. The device is not intended for whole body pediatric imaging
- Lot codes and dates
61 of 61 codes
62-021269-005482-0023-RC82-003482-007282-027482-05878S-066882-171082-180382-214782-262082-275482-281582-301482-323482-7010-MH86-025486-035486-107889-050589-050989-059589-060589-098789-104889-177689-183789-213289-230389-233589-234889-235089-261089-26458S-00668S-00798S-03418S-05628S-0615-C8S-08478S-0849-C8S-13128S-19718S-2015-N8S-21168S-21178S-21998S-22048S-23208S-2411P4-0097-RP4-0101-RP4-0325-RP4-0346-LP4-0477-LP6-0432-RW2-0012W2-0580-RW2-0591-R
- Amount recalled
- Part of a total of 82 units distributed.
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
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. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and
This product could cause temporary or reversible health problems — stop using it.
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