FDA Device

GE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and Innova 2000S mobile version. Cardiovascular Imaging System.

Hazard

Incorrect screws were used for mounting the detector which may lead to a possible part falling onto a patient.

What You Should Do

Remedy

GEHC is issuing a validated field action 3/6/2006 to correct the issues. Existing screws/bolts will be replaced using correct torque with screws containing cotter pins. Loctite liquid glue will be applied. Service manuals have been updated with instructions for using correct screws and torque. The field action is being implemented via Field Modification Instruction (FMI) 12033.

Products

GE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and Innova 2000S mobile version. Cardiovascular Imaging System.
Brand
GE Healthcare
UPC
all serial numbers

Units Affected

856 (534 domestic and 322 OUS)