Recall Z-2251-2012— GE OEC Medical Systems, Inc

Name: FDA recall Z-2251-2012
Creator: U.S. Food and Drug Administration
Published: 2009-06-22

Class I · Terminated

Class I FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2009-06-22, terminated 2012-09-28. It names 6 FDA 510(k) clearances: K994270, K990919, K983529 and 3 more. Product: OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical procedures. It is intended for use in medical conditions that may benefit from the use of stereotactic surgical 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: GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus, 3500, 3500 plus, ConneCTstat, and ConneCTstat Plus Surgical Navigation equipment..

Recalling firm: GE OEC Medical Systems, Inc
Classification: Class I
Status: Terminated
Initiated: 2009-06-22
Terminated: 2012-09-28
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

6 on FDA's record

K994270 — INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000Visualization Technology, Inc.·cleared 2000-03-09
K990919 — STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAGVisualization Technology, Inc.·cleared 1999-04-15
K983529 — INSTATRAK 3000Visualization Technology, Inc.·cleared 1998-12-31
K982994 — SKULL BASE INSTATRAK SYSTEMVisualization Technology, Inc.·cleared 1998-11-16
K981998 — PEDIATRIC INSTATRAK SYSTEMVisualization Technology, Inc.·cleared 1998-08-21
K960330 — INSTATRAKVisualization Technology, Inc.·cleared 1996-04-08

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 IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical procedures. It is intended for use in medical conditions that may benefit from the use of stereotactic surgical 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

GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus, 3500, 3500 plus, ConneCTstat, and ConneCTstat Plus Surgical Navigation equipment.

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