Z-1263-2019Class II

Nm/ct 860

Name: Z-1263-2019 Nm/ct 860
Creator: GE Healthcare, LLC
Published: 2019-03-20
License: https://open.fda.gov/license/

GE Healthcare / initiated 2019-03-20 / Terminated / root cause: design

FDA source

GE Healthcare, LLC began a recall of NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the... on 2019-03-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1263-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-20
Posted: 2019-05-03
Terminated: 2020-10-05
Recalling firm: GE Healthcare
Product: NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body and vascular X-ray Computed Tomography applications.
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: design
FDA root cause: Device Design
Action: GE Healthcare sent an Urgent Medical Device Correction letter dated March 20, 2019 to affected customers. The letter identified the affected product, problem and actions to be taken. GE Healthcare will inspect and, if required, correct all affected products at no cost to you to ensure that all design redundancies are in place. A GE Healthcare representative will contact you to arrange for the correction. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 6 units
Distribution: US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK
Product codes and lots: Mfg. Lot or Serial # System ID Model, Catalogue or Code # 860Y62005 SHIPPED (GON 4736850) H3908AD 850X61003 401793860NM H3908AD 860X62001 E6843969 H3908AE 870X64005 HC4387NU05 H3100AS 860Y62004 083026212959219 H3908AD 860X62002 PL0399NM01 H3908AD

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1263-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1257-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02
Z-1258-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02
Z-1259-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02
Z-1260-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02
Z-1261-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02
Z-1262-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02
Z-1263-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02
Z-1264-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02
Z-1265-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02
Z-1266-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02

Product code JAK

K173816Class IINm/ct 850, Nm/ct 860GE Healthcare / cleared 2018-04-17

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)