NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging sy...
FDA Device Recall #Z-1261-2019 — Class II — March 20, 2019
Recall Summary
| Recall Number | Z-1261-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 20, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 37 units |
Product 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.
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.
Distribution Pattern
US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK
Lot / Code Information
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
Other Recalls from GE Healthcare, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1566-2022 | Class II | (1) GE Centricity Universal Viewer 6.0, Model 2... | Jul 15, 2022 |
| Z-1430-2022 | Class II | SIGNA Premier magnetic resonance scanner, model... | Jun 24, 2022 |
| Z-1466-2022 | Class II | Centricity PACS Software Version 7.0 SP0.0.4.7 | Jun 14, 2022 |
| Z-1333-2022 | Class II | GE Centricity Universal Viewer Zero Footprint. ... | Jun 8, 2022 |
| Z-1511-2022 | Class II | Service manuals for the CT, PET, or NM table as... | Jun 2, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.