SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images,
Check against the official notice below — it lists the full affected range.
GE Medical Systems is recalling 16 SIGNA Pioneer magnetic resonance (MR) imaging systems worldwide due to a hazard in the Table Control Box (TCB). The TCB contains ferrous material that could become unexpectedly attracted to the MR system's powerful magnetic field during servicing activities, potentially causing serious injury to service personnel who attempt to remove the TCB from the magnetic field. No injuries have been reported from this issue to date. The affected systems are located in South Carolina, North Carolina, Australia, Canada, France, Germany, Japan, and Turkey.
The recall affects two systems in the United States and 14 systems outside the United States. The specific system identification numbers and serial numbers for all 16 affected units are listed in the recall documentation. The record does not specify what actions affected consumers or facilities should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Ferrous material in the SIGNA Pioneer Table Control Box (TCB) could cause unexpected attraction to the MR system's high strength magnetic field during servicing activities. This could create a potential risk of serious injury to service personnel who attempt to inappropriately remove the TCB from the magnetic field. There have been no events reported as a result of this issue. Clinical scanni
Reason for recall: Ferrous material in the SIGNA Pioneer Table Control Box (TCB) could cause unexpected attraction to the MR system's high strength magnetic field during servicing activities. This could create a potential risk of serious injury to service personnel who attempt to inappropriately remove the TCB from the magnetic field. There have been no events reported as a result of this issue. Clinical scanni Distribution: Worldwide Distribution - US Nationwide in the states of SC, NC and the countries of Australia, Canada, France. Germany, Japan and Turkey. Quantity: 16 (2 US; 14 OUS) Lot/code info: Mfg Lot or Serial # System ID 001612TA1 N/A 001718TA6 336397P3T 002331TA7 083132425984 001719TA4 250598MR1 001424TA1 M2850013 001537TA0 TP0008MR07 001662TA6 157022MR01 001184TA1 ZC0002 001652TA7 N/A 002227TA7 ZC0003 002278TA0 ZC0004 002330TA9 ZC0006 002529TA6 N/A 001485TA2 34026MRS05 002279TA8 34225MRS02 002395TA2 34185MRS02
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.