Z-0858-2021Class II

Optima NM/CT 640, Model number 3101RL -

Name: Z-0858-2021 Optima NM/CT 640, Model number 3101RL -
Creator: GE Healthcare, LLC
Published: 2020-12-10
License: https://open.fda.gov/license/

GE Healthcare / initiated 2020-12-10 / Open, Classified / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in... on 2020-12-10. FDA classified it as Class II and gives the reason as "GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0858-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-12-10
Posted: 2021-01-13
Recalling firm: GE Healthcare
Product: Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated their action by letter to the consignees on 12/10/2020. The letter explained the issue and stated that GE would inspect, and if required, correct the affected units. Questions and concerns may be directed to GE Healthcare Service at 1-800-437-1171 or the consignee's local Service Representative.
Quantity in commerce: 7 units
Distribution: Worldwide
Product codes and lots: Serial Numbers: 64GY51017, 64GY51020, 64GY51022, 64GZ51028, 64GZ51030, 64GZ51029, 64GY51021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0858-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0853-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-13
Z-0854-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-13
Z-0855-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-13
Z-0856-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-13
Z-0857-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-13
Z-0858-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-13

Product code KPS

K121019Class IIOptima Nm/ct 640GE Healthcare / cleared 2012-04-19

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)