Z-1545-2021Class II

NM/CT 850 Nuclear Medicine / CT Scanners

Name: Z-1545-2021 NM/CT 850 Nuclear Medicine / CT Scanners
Creator: GE Healthcare, LLC
Published: 2021-02-07
License: https://open.fda.gov/license/

GE Healthcare / initiated 2021-02-07 / Open, Classified / root cause: design

FDA source

GE Healthcare, LLC began a recall of NM/CT 850 Nuclear Medicine / CT Scanners on 2021-02-07. FDA classified it as Class II and gives the reason as "GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1545-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-02-07
Posted: 2021-05-11
Recalling firm: GE Healthcare
Product: NM/CT 850 Nuclear Medicine / CT Scanners
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.
Root cause tag: design
FDA root cause: Device Design
Action: GE Healthcare will send a customer notification letter describing the issue and providing safety instructions for immediate mitigation of the issue. Customers were instructed, they may continue to use the system and follow workaround instructions (zoom=1 for specific WB protocol) until the correction is provided. GE Healthcare corrective action is the development and deployment of a software update on all affected smart console IB systems at no cost to the customer. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 242 in total (17 units US)
Distribution: Worldwide distribution - US Nationwide
Product codes and lots: GTIN*00840682140775

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1545-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1545-2021	Class II	Ongoing	FDA Mandated	2021-05-19	2021-05-11
Z-1546-2021	Class II	Ongoing	FDA Mandated	2021-05-19	2021-05-11
Z-1547-2021	Class II	Ongoing	FDA Mandated	2021-05-19	2021-05-11

Product code KPS

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)