Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear ...
FDA Device Recall #Z-1257-2019 — Class II — March 20, 2019
Recall Summary
| Recall Number | Z-1257-2019 |
| 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 | 57 units |
Product Description
Discovery NM 630 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 # 63GY50074 334287NM630 H3101RH 63GX50024 501450D630 H3101RH 630X22925 310657D630 H3100JY 630X22921 951682NMDISC H3100JY 63GY50067 719776DISCNM H3101RH 63GX50001 863494NM H3101RH 630X22923 904296NM H3100JY 63GX50037 305223D630A H3101RH 63GX50060 305223D630B H3101RH 63GX50034 478289DIS H3101RH 63GX50014 618998NM H3101RH 63GX50019 270745NM1 H3101RH 63GY50078 269966NMDISC H3101RH 63GX50021 906225CARDNM2 H3101RH 63GX50022 906225CARDNM1 H3101RH 63GX50018 269637NM630 H3101RH 63GX50009 NM555658 H3101RH 63GY50080 4695517NM11 H3101RH 63GY50077 919954NMDISC H3101RH 63GX50043 828286RHD630 H3101RH 63GX50020 402481D630C H3101RH 63GX50040 973450CARD630 H3101RH 63GX50054 973450D630 H3101RH 63GX50008 856641NM H3101RH 63GY50079 SHIPPED (GON 4722927) H3101RH 63GX50061 702962NM1 H3101RH 63GX50035 702962NM2 5376204-31 63GX50050 702388DISC H3101RH 63GX50062 702724DISCNM H3101RH 63GX50032 513861NM H3101RH 63GX50055 513861NM1 H3101RH 63GX50013 740MGD630 H3101RH 63GX50047 440743D630 H3101RH 63GX50002 419251NM H3101RH 63GX50025 330841DISCNM H3101RH 63GX50033 330841DISCNM2 H3101RH 63GX50038 918756D630 H3101RH 63GX50044 803865D630 H3101RH 63GY50068 854529NMDISC H3101RH 63GY50069 901516NM 5376204-31 63GX50016 615873NM H3101RH 63GY50075 SHIPPED (GON 4561460) H3101RH 63GX50012 832505D630 H3101RH 63GX50005 713440NM630B H3101RH 63GX50029 281MHNE630 H3101RH 630X22919 972258NM630 H3100JY 63GX50046 210351NM H3101RH 63GX50049 281MWL630B H3101RH 63GX50039 281MWL630A H3101RH 63GX50030 434243DIS H3101RH 63GX50011 LGMONT630 H3101RH 63GX50017 540316NM630 5791570 630X22922 804764D630C H3100JY 630X22924 UESS01NU03 H3100JY 63GX50048 418404NU02 H3101RH 63GX50041 083026202460918 H3101RH NT2PG1800001BH NT8003 5376204-31-1
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.