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Terminated

OEC UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures

FDA Recall Z-0192-2015 · Posted 2014-11-07

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2014-10-03
Date Terminated2015-03-23
Product Quantity2

Reason for Recall

GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.

Firm Action

On October 3. 2014. GE Healthcare Surgery began distributing an Urgent Medical Device Correction letter to customers to inform them of the issue and provide instructions for immediate mitigation of the issue. The letter was sent to 3 titles at each facility affected: 1.1 Facility Administrator. 2.1 Director/Manager of Radiology and Radiologists, 3.) Radiology Department. Firm will track all service requests for the field action to completion. These service requests will document the inspection and component replacement (if applicable) on the affected units. Exceptions to completion of the service request will be recorded. Records of field action completion will be retained per our processes and procedures. No product is being returned.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993687UROVIEW 2800Ge Dec Medical Systems · 1999-12-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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