CLASS II Device recall · Reported 8 May 2019 · FDA Enforcement Report

Discovery NM recalled by GE Healthcare

GE Healthcare is recalling Discovery NM 630. The recall was initiated on 20 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMfg. 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

Quantity recalled57 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1257-2019
FDA event ID: 82582
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 20 Mar 2019
FDA classified: 2 May 2019
Reported: 8 May 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

20 Mar 2019	Recall initiated by company
2 May 2019	Classified by FDA	+43 days
8 May 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK

Questions about this recall

Is Discovery NM 630 recalled?

Yes. GE Healthcare recalled Discovery NM 630 on 20 Mar 2019. The recall is Class II and its status is Terminated. Recall number Z-1257-2019.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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