Z-1747-2019Class II

Optima PET/CT 560, 560FX

Name: Z-1747-2019 Optima PET/CT 560, 560FX
Creator: GE Healthcare, LLC
Published: 2019-02-12
License: https://open.fda.gov/license/

GE Healthcare / initiated 2019-02-12 / Open, Classified

FDA source

GE Healthcare, LLC began a recall of Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and... on 2019-02-12. FDA classified it as Class II and gives the reason as "GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1747-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-02-12
Posted: 2019-06-19
Recalling firm: GE Healthcare
Product: Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
FDA root cause: Radiation Control for Health and Safety Act
Action: GE Healthcare sent a notification letter to affected customer (Hospital Administrators/Risk Managers. Managers of Radiology/Cardiology, Radiologist/Cardiologist). The letter identified the affected product, problem and actions to be taken. Customers were informed GE Healthcare will without charge, remedy the defect or bring the product into compliance. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 1113 in total
Distribution: Nationwide Distribution
Product codes and lots: CT 560, 560FX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1747-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1745-2019	Class II	Ongoing	FDA Mandated	2019-06-26	2019-06-19
Z-1746-2019	Class II	Ongoing	FDA Mandated	2019-06-26	2019-06-19
Z-1747-2019	Class II	Ongoing	FDA Mandated	2019-06-26	2019-06-19
Z-1748-2019	Class II	Ongoing	FDA Mandated	2019-06-26	2019-06-19
Z-1749-2019	Class II	Ongoing	FDA Mandated	2019-06-26	2019-06-19
Z-1750-2019	Class II	Ongoing	FDA Mandated	2019-06-26	2019-06-19

Product code KPS

K081496Class IIOptima Pet/ct 560Ge Medical Systems, LLC / cleared 2008-06-12

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)