Details of the OpenSpeed and Ovation Pinch Point Hazard Customer Letter Dated March 22, 2009 and Oct 29, 2008 respective…

What are the Details of the OpenSpeed and Ovation Pinch Point Hazard Customer Letter Dated March 22, 2009 and Oct.29, 2008 respectively? See Long Description A pinch point hazard has been identified on HFO3, HFO4, HFO5 and MFO2-5 systems. The FMI's shown below, which are not yet released as of this writing on May 14, 2009, address the problem. At one site, a patient's hand was pinched between the CTL coil and the magnet's upper pole face of an OpenSpeed system, when the patient grabbed onto the coil's ribs while the table was in motion driving to the scan position. iTrak # 13205450. FMI 67706 HFO3 M4 Service Pack 2 (HFO3 Pinch Point Hazard) FMI 67624 HFO4 M4 + SP3 UPGRADE (HFO4 Pinch Point Hazard) FMI 67704 HFO5 M4 + SP4 UPGRADE (HFO5 Pinch Point Hazard) FMI 67621 MFO4 M4 + SP2 UPGRADE (MFO4 Pinch Point Hazard) These FMI's have been released as of May 14, 2009; FMI 67619 MFO2 M4 + SP1 UPGRADE FMI 67620 MFO3 M4.1 + SP2 UPGRADE FMI 67622 MFO5 M4 + SP2 UPGRADE These FMIs implement a change in software in the operator workflow, as follows. (There are no hardware changes). After installation of these FMIs, only for certain coils , the operator will be required to press and hold in the [Advance to Scan] button on the magnet enclosure until the patient has been driven in partway into the bore, past the point where a pinch hazard could occur, depending on the coil. If the operator releases this button prior to this point the table will stop moving. If this happens they just need to press and hold in the button again. This change is for patient safety, to insure the operator observes the patient while the table is in motion to prevent a pinch. Previous to this change the operator could just touch this button once and the patient would be driven all the way to the scan position. A customer letter will accompany the FMIs. The customer may receive a copy of this letter from GE detailing these changes prior to release of the FMI. Service personnel need to know these details now to be prepared for questions.