Recall Z-2025-2012— GE OEC Medical Systems, Inc

Name: FDA recall Z-2025-2012
Creator: U.S. Food and Drug Administration
Published: 2007-11-19

Class II · Terminated

Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2007-11-19, terminated 2013-01-28. It names one FDA 510(k) clearance: K041932. Product: OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgery technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.. 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 recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure..

Recalling firm: GE OEC Medical Systems, Inc
Classification: Class II
Status: Terminated
Initiated: 2007-11-19
Terminated: 2013-01-28
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K041932 — OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEMGe Oec Medical Systems, Inc.·cleared 2004-08-18

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 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgery technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.

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 recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure.

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