GE OEC Medical Systems, Inc: Medical Device Recall in 2012 - (Recall #: Z-2251-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: June 22, 2009

Date Posted: September 5, 2012

Recall Number: Z-2251-2012

Event ID: 62715

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.

Status: Terminated

Product Quantity: 768 units

Code Information:

All serial numbers.

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and the countries of India, Japan, Canada, Switzerland, Italy, United Kingdom, Germany, Austria, Hong Kong, France, and Denmark.

Voluntary or Mandated:

Voluntary: Firm initiated