CLASS II Device recall · Reported 19 Nov 2014 · FDA Enforcement Report

Brivo NM615, is an all-purpose recalled by GE Healthcare

GE Healthcare is recalling Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system, distributed nationwide in the US. The recall was initiated on 14 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMfg Lot or Serial # System ID 24013 702304NM615 24001 406222LN615 24003 478272NM 24004 405456NM615 24006 806665NM615 24019 030151NU17 24011 NM24011 24014 NM24014 24020 NM24020 24015 NM24015 24016 GON1427120 24002 HC0541NU03 24009 387171NU01 24010 HC3366NU02 24007 083026241010212 00000000116BH4 083026040018413 00000000117BH2 083026020020313 24008 A5635609 24017 NM24017 00000000084BH4 PK1267NM01 24005 ZA2446NM01 24012 ZA1819NM04

Quantity recalled22

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-0189-2015
FDA event ID: 69570
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 14 Oct 2014
FDA classified: 7 Nov 2014
Reported: 19 Nov 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

14 Oct 2014	Recall initiated by company
7 Nov 2014	Classified by FDA	+24 days
19 Nov 2014	Published in enforcement report	+12 days

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

Reason for recall

GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.

Product as listed by the FDA

Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3100WZ, H2401MP, H2401MN, H2401MT, H2401MR, H2401MW, H2401NJ. Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produce cross-sectional images through computer reconstruction of the data. The Brivo NM 615 system is intended for General Nuclear Medicine imaging procedures using variety of scanning modes supported by various acquisition types. This generic type of device may include signal analysis and display equipment, patient and equipment supports, and accessories

Where it was distributed

Worldwide Distribution: US (nationwide) including Guam, Puerto Rico and DC; and countries of: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELRARUS, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, GREECE, GUADELOUPE, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA,MARTINIQUE, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN,SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, URUGUAY, VENEZUELA, VIET NAAM.

Nationwide District of Columbia Georgia Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

Mfg Lot or Serial # System ID 24013 702304NM615 24001 406222LN615 24003 478272NM 24004 405456NM615 24006 806665NM615 24019 030151NU17 24011 NM24011 24014 NM24014 24020 NM24020 24015 NM24015 24016 GON1427120 24002 HC0541NU03 24009 387171NU01 24010 HC3366NU02 24007 083026241010212 00000000116BH4 083026040018413 00000000117BH2 083026020020313 24008 A5635609 24017 NM24017 00000000084BH4 PK1267NM01 24005 ZA2446NM01 24012 ZA1819NM04

Where was it sold?

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

5 other products · FDA event 69570

This product is part of a recall event; the main page for the event is Discovery NM 630, dual detector free-geometry integrated recalled.

Reported	Class	Recall	Company	Reason	Where
19 Nov 2014	CLASS II	Discovery NM 630, dual detector free-geometry integrated recalled	GE Healthcare	Other	Nationwide
19 Nov 2014	CLASS II	Discovery NM/CT 670 dual detector free-geometry integrated recalled	GE Healthcare	Other	Nationwide
19 Nov 2014	CLASS II	Optima NM/CT recalled by GE Healthcare	GE Healthcare	Other	Nationwide
19 Nov 2014	CLASS II	Infinia (including Infinia, and Infinia II VC Hawkeye recalled	GE Healthcare	Other	Nationwide
19 Nov 2014	CLASS II	Varicam/VG and VG Hawkeye devices recalled by GE Healthcare	GE Healthcare	Other	Nationwide

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