SIGNA Pioneer MR Systems Product Usage: The SIGNA recall
SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolution, high…
Why was SIGNA Pioneer MR Systems Product Usage: The SIGNA recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolution, high…
- Recalling firm
- GE Medical Systems, LLC
- Quantity
- 16 (2 US; 14 OUS)
- Distribution
- Worldwide Distribution - US Nationwide in the states of SC, NC and the countries of Australia, Canada, France. Germany, Japan and Turkey.
- Recall date
- April 13, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)