Z-0606-2019Class II

Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases...

Name: Z-0606-2019 Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases...
Creator: GE Healthcare, LLC
Published: 2018-05-24
License: https://open.fda.gov/license/

GE Healthcare / initiated 2018-05-24 / Completed

FDA source

GE Healthcare, LLC began a recall of Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of... on 2018-05-24. FDA classified it as Class II and gives the reason as "When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could result in these not shutting off...". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-0606-2019
Classification: Class II
Status: Completed
Initiated: 2018-05-24
Posted: 2018-12-13
Recalling firm: GE Healthcare
Product: Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could result in these not shutting off all power to the entire system as intended, resulting in a potential electric hazard.
FDA root cause: Component change control
Action: The firm initiated the recall by letter on 05/24/2018. The letter explained the issue and requested the UPS(s) be disconnected from the system until the system could be repaired.
Quantity in commerce: 4 units
Distribution: CA, DC, OH, UT, WI, Canada
Product codes and lots: GTIN 00840682124393 Serial Numbers: DDRW34032, DDRX34038, DDRX34041, DDRX34045

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0606-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0606-2019	Class II	Completed	Voluntary: Firm initiated	2018-12-19	2018-12-13
Z-0607-2019	Class II	Completed	Voluntary: Firm initiated	2018-12-19	2018-12-13
Z-0608-2019	Class II	Completed	Voluntary: Firm initiated	2018-12-19	2018-12-13

Product code KPS

K093514Class IIDiscovery Model Nm/ct 670Ge Medical Systems F.I. Haifa / cleared 2009-12-10

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)