NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table, Remote Control Unit and NM operation console.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Mfg. Lot or Serial # System ID Model, Catalogue or Code # 830Y60040 256737NM H3910AC 830X60004 901227NM1 H3910AC 830X60001 479338N830 H3910AC 830Y60036 860496NM830 H3910AC 830X60018 772468NM830 H3910AC 830X60026 954721NM H3910AC 830X60012 813315D830 H3910AC 830Y60030 813874D830 H3910AC 830X60011 225761NM1 H3910AC 830X60016 225761NM H3910AC 830Y60029 410554NM H3910AC 830X60019 573458NM H3910AC 830X60027 603742NM830 H3910AC 830X60014 718238D830 H3910AC 830X60015 585396NM H3910AC 830X60006 716862NM830 H3910AC 830Y60031 631726D830 H3910AC 830X60003 585786NM830 H3910AC 830X60021 615316NM830 H3910AC 830Y60034 936CMC830 H3910AC 830X60028 361275NM830 H3910AC 830X60017 956323NM830 H3910AC 830Y60035 304526D830 H3910AC 830X60002 100039NU05 H3910AC 830X60022 705743DNM830 H3910AC 830X60013 M4040557 H3910AC 830Y60032 362759NU01 H3910AC 830Y60033 NS0103 H3910AC 830Y60038 NS0104 H3910AC NT3AG1900002BH NS0204 5376204-32-1 NT3AG1900003BH NS0205 5376204-32-1 NT3AG1900001BH NS0203 5376204-32-1 NT3AG1800001BH NS0201 5376204-32-1 830X60020 NS0101 H3910AC 830X60005 0850260165 H3910AC 830X60008 0850260166 H3910AC 830X60007 752030NU01 H3910AC
- 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:
- During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table, Remote Control Unit and NM operation console.
Product Codes/Lot Numbers:
Mfg. Lot or Serial # System ID Model, Catalogue or Code # 830Y60040 256737NM H3910AC 830X60004 901227NM1 H3910AC 830X60001 479338N830 H3910AC 830Y60036 860496NM830 H3910AC 830X60018 772468NM830 H3910AC 830X60026 954721NM H3910AC 830X60012 813315D830 H3910AC 830Y60030 813874D830 H3910AC 830X60011 225761NM1 H3910AC 830X60016 225761NM H3910AC 830Y60029 410554NM H3910AC 830X60019 573458NM H3910AC 830X60027 603742NM830 H3910AC 830X60014 718238D830 H3910AC 830X60015 585396NM H3910AC 830X60006 716862NM830 H3910AC 830Y60031 631726D830 H3910AC 830X60003 585786NM830 H3910AC 830X60021 615316NM830 H3910AC 830Y60034 936CMC830 H3910AC 830X60028 361275NM830 H3910AC 830X60017 956323NM830 H3910AC 830Y60035 304526D830 H3910AC 830X60002 100039NU05 H3910AC 830X60022 705743DNM830 H3910AC 830X60013 M4040557 H3910AC 830Y60032 362759NU01 H3910AC 830Y60033 NS0103 H3910AC 830Y60038 NS0104 H3910AC NT3AG1900002BH NS0204 5376204-32-1 NT3AG1900003BH NS0205 5376204-32-1 NT3AG1900001BH NS0203 5376204-32-1 NT3AG1800001BH NS0201 5376204-32-1 830X60020 NS0101 H3910AC 830X60005 0850260165 H3910AC 830X60008 0850260166 H3910AC 830X60007 752030NU01 H3910AC
Distribution:
Distributed in: US, UK
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1261-2019
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