OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
FDA Recall Z-1469-2017 · Posted 2017-02-27
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Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeOXO
Date Initiated2017-02-21
Date Terminated2017-04-24
Product Quantity1
Reason for Recall
OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures.
Firm Action
On February 21, 2017, an Urgent Medical Device Correction letter was sent to one consignee with an affected unit; a field service representative hand delivered the customer communication.
Root Cause
Process control
Distribution Pattern
One consignee in CA.
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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