SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Mfg. Lot or Serial # System ID To be provided GON4833100 01264 860536MR3T KZTBL1700064TJ 860871MR3T KZTBL1800069TJ RADNETMR1700 KZTBL1800022TJ 508872PMR 01302 RADNETMR1708 KZTBL1900130TJ 301698MR1 KZTBL1900071TJ 704333PIO KZTBL1900110TJ 631751MR KZTBL1900107TJ RADNETMR1707 KZTBL1900121TJ 803936LMCMR2 033-4-1532 281HMI750W To be provided 83199160995 To be provided M24313812 To be provided M2850013 To be provided TP0013MR01 To be provided PNUE04MR02 To be provided TP0008MR07 To be provided 083027823408018 To be provided 083027823888617 To be provided GON4826677 To be provided GON4762453 To be provided B5142305 To be provided ZC0002 To be provided ZC0034 To be provided ZC0001 To be provided ZC0306 To be provided GON4795546 To be provided 222768MR01 To be provided 34340MRS02 To be provided 10627MRS02
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- GE Healthcare, LLC
- Reason for Recall:
- It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Product Codes/Lot Numbers:
Mfg. Lot or Serial # System ID To be provided GON4833100 01264 860536MR3T KZTBL1700064TJ 860871MR3T KZTBL1800069TJ RADNETMR1700 KZTBL1800022TJ 508872PMR 01302 RADNETMR1708 KZTBL1900130TJ 301698MR1 KZTBL1900071TJ 704333PIO KZTBL1900110TJ 631751MR KZTBL1900107TJ RADNETMR1707 KZTBL1900121TJ 803936LMCMR2 033-4-1532 281HMI750W To be provided 83199160995 To be provided M24313812 To be provided M2850013 To be provided TP0013MR01 To be provided PNUE04MR02 To be provided TP0008MR07 To be provided 083027823408018 To be provided 083027823888617 To be provided GON4826677 To be provided GON4762453 To be provided B5142305 To be provided ZC0002 To be provided ZC0034 To be provided ZC0001 To be provided ZC0306 To be provided GON4795546 To be provided 222768MR01 To be provided 34340MRS02 To be provided 10627MRS02
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0876-2020
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