Recall Z-2125-2012— GE OEC Medical Systems, Inc

Name: FDA recall Z-2125-2012
Creator: U.S. Food and Drug Administration
Published: 2007-03-27

Class II · Terminated

Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2007-03-27, terminated 2012-08-02. It names one FDA 510(k) clearance: K021049. Product: OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.. Reason: 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.

Recalling firm: GE OEC Medical Systems, Inc
Classification: Class II
Status: Terminated
Initiated: 2007-03-27
Terminated: 2012-08-02
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K021049 — OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEMGe Oec Medical Systems·cleared 2002-04-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.