OEC Uroview 2800 fluoroscopic x-ray system with 3 Phase Power Distribution Box option (Wonder Box) , Model Numbers: 882082-01, 882082-02, 886765-01, GE Healthcare, Surgery, Salt Lake City, UT.
FDA Recall Z-0515-2007 · Posted 2007-02-15
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Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2007-01-15
Date Terminated2011-12-09
Product Quantity277 units
Reason for Recall
Uroview 2800 system with 3 Phase Power Distribution Box (Wonder Box) option can present a shock hazard to the user if the access door to the power box is not completely closed when the unit is powered on. .
Firm Action
Consignees were notified by letter on 01/15/2007. Instructions were given to position and not move the dual monitors until inspection and correction by GE personnel. For the affected units with a 3 phase power distribution box, users were cautioned to ensure that the access door to the power box is completely closed when the unit is powered on to prevent a shock hazard.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Canada, China, France, Germany, Hong Kong, Italy, Japan, Singapore, South Africa, Switzerland, and Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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