Discovery MR450 1.5T recall
Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imaging System
Why was Discovery MR450 1.5T recalled?
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
System ID: 714957MR, 209225VC450, 858939MR4, 858939MR3, 202476MR1, HSS75MR450, HSSMAGNETF, 713566SMITH3, 713566SMITH1, 832522MR2, 920830MR450, 304256MR2, 250727MR2, DK1083MR06, FI1052MR01, RMUE01MR04, A5624132, D5354206, SA1058MR02, SA1011MR03, CPZ43620, 00242MRS02, 05217MRS02,
- Product
- Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imaging System
- Recalling firm
- GE Medical Systems, LLC
- Quantity
- 23 units
- Distribution
- Worldwide distribution.
- Recall date
- August 14, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)