Recall Z-2236-2012— GE OEC Medical Systems, Inc
Class II · Terminated
Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2006-10-11, terminated 2012-08-22. It names one FDA 510(k) clearance: K003510. Product: OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated 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 had recalled certain OEC InstaTrak 3500 Carts due to the potential for the cart to tip over when the arm of the imaging device is extended during use..
- Recalling firm
- GE OEC Medical Systems, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2006-10-11
- Terminated
- 2012-08-22
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-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 InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated 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 had recalled certain OEC InstaTrak 3500 Carts due to the potential for the cart to tip over when the arm of the imaging device is extended during use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.