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

NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual recalled

GE Healthcare is recalling NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual. 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 # 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

Quantity recalled37 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-1261-2019
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

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.

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

Why was it recalled?

Which lots 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

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

Other products in this recall event

9 other products · FDA event 82582

This product is part of a recall event; the main page for the event is Nm/CT 870 Czt recalled by GE Healthcare.

Reported	Class	Recall	Company	Reason	Where
8 May 2019	CLASS II	Nm/CT 870 Czt recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
8 May 2019	CLASS II	NM/CT 870 DR recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
8 May 2019	CLASS II	Discovery NM/CT 670 DR recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
8 May 2019	CLASS II	Optima NM/CT recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
8 May 2019	CLASS II	NM/CT recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
8 May 2019	CLASS II	NM/CT recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
8 May 2019	CLASS II	Discovery NM/CT 670 CZT recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
8 May 2019	CLASS II	Discovery NM/CT 670 ES recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
8 May 2019	CLASS II	Discovery NM recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI

More recalls from GE Healthcare

All 512

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	Signa Premier systems recalled by GE Healthcare	GE Healthcare	Other	Nationwide
11 Mar 2026Device	CLASS II	Centricity Universal Viewer Zero Footprint Client recalled	GE Healthcare	Device Malfunction	Nationwide
24 Dec 2025Device	CLASS II	GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological recalled	GE Healthcare	Device Malfunction
9 Apr 2025Device	CLASS II	Centricity Pacs-iw (Pacs-iw) recalled by GE Healthcare	GE Healthcare	Other	IL
9 Apr 2025Device	CLASS II	Centricity Pacs-iw with Universal Viewer recalled by GE Healthcare	GE Healthcare	Other	IL

Other Imaging Equipment recalls

All 2,336

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled	Canon Medical System USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederl	Potency & Assay