Z-0189-2015Class II

Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN...

Name: Z-0189-2015 Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN...
Creator: GE Healthcare, LLC
Published: 2014-10-14
License: https://open.fda.gov/license/

GE Healthcare / initiated 2014-10-14 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3100WZ, H2401MP... on 2014-10-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0189-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-14
Posted: 2014-12-16
Terminated: 2015-02-27
Recalling firm: GE Healthcare
Product: 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
Product code: KPS System, Tomography, Computed, Emission
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter, GEHC Ref# 40860, dated October 14, 2014 to its consignees. The letter described the Safety Issue, safety Instructions, Affected Product Details, Product Correction, actions to be taken and Contact Information. For questions, consignees in the United States, can contact 1-800-437-1171, for other countries they can contact their GE Healthcare Service Representative.
Quantity in commerce: 22
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0189-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0184-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-07
Z-0185-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-07
Z-0186-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-07
Z-0187-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-07
Z-0188-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-07
Z-0189-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-07

Product code KPS

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)