Z-2236-2012Class II

OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical...

Name: Z-2236-2012 OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical...
Creator: GE OEC Medical Systems, Inc
Published: 2006-10-11
License: https://open.fda.gov/license/

GE Healthcare / initiated 2006-10-11 / Terminated / root cause: design

FDA source

GE OEC Medical Systems, Inc began a recall of OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical... on 2006-10-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2236-2012
Classification: Class II
Status: Terminated
Initiated: 2006-10-11
Posted: 2012-08-22
Terminated: 2012-08-22
Recalling firm: GE Healthcare
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.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: GE Healthcare sent an "URGENT SAFETY ADVISORY NOTICE" dated October 11, 2006 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter stated that GEHC OEC Field Service Engineers would be contacting their facility to place a caution label on the articulating monitor arm of the cart and to provide a revised operators manual that will contain additional information on the safe usage of the cart. Until a GEHC Engineer had taken the actions described, they advised their consignees to exercise caution when fully extending the articulating monitor arm on the device to avoid potentially tipping over the cart. Contact the firm at 800-874-7378 for questions regarding this notice.
Quantity in commerce: 99 units
Distribution: Nationwide Distribution.
Product codes and lots: Model number A857680 with various serial numbers (refer to consignee list).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2236-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2236-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-21

Product code LLZ

K003510Class IIInstatrak System with Fluorocat, Model It3500Visualization Technology, Inc. / cleared 2001-02-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)