Z-1264-2019Class II

NM/CT 870 CZT, Model/Catalogue/Code # H3906CW

Name: Z-1264-2019 NM/CT 870 CZT, Model/Catalogue/Code # H3906CW
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 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures... 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-1264-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-20
Posted: 2019-05-03
Terminated: 2020-10-05
Recalling firm: GE Healthcare
Product: NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT 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, cardiac 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: 16 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 87CY63017 SHIPPED (AO 1630621) 87CX63007 AH0101NM05 87CX63014 030078NU28 87CX63008 190020NU01 87CX63006 030240NU11 87CX63015 705743NM870 87CX63011 M4184879 87CX63003 M9886873 87CX63004 X171582003 87CX63009 M171582018 87CX63010 UC1796NU01 87CX63013 NO1068MN18 87CX63005 A004NU20 87CX63002 C028NU01 87CX63012 C028NU02 87CX63001 900010NU12

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1264-2019
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

K153402Class IIDiscovery NM/CT 670 CZTGE Healthcare / cleared 2016-01-21

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)