GE OEC Medical Systems, Inc: Medical Device Recall in 2012 - (Recall #: Z-2025-2012)

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 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.

Product Classification:

Class II

Date Initiated: November 19, 2007

Date Posted: July 25, 2012

Recall Number: Z-2025-2012

Event ID: 62404

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.

Status: Terminated

Product Quantity: 726 units

Code Information:

Part numbers: 00-887200-01; 00-887200-03; 00-887201-01; 00-887201-03; 00-887202-01; 00-887202-03; 00-887204-03; 00-887207-03; 00-887206-03. Along with all associated serial numbers.

Distribution Pattern:

Worldwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated