OEC MiniView 6800 의 리콜

Recall

69474

Class 2

Z-0193-2015

2014-10-03

2014-11-07

Terminated

United States

2015-03-23

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130739

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.

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.