NM 830 Product Usage: The Discovery NM 630 is an recall
NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging…
Why was NM 830 Product Usage: The Discovery NM 630 is an recalled?
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.
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 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
- Product
- NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging…
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 37 units
- Distribution
- US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK
- Recall date
- May 8, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)