Z-1056-2023Class I

GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X...

Name: Z-1056-2023 GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X...
Creator: Ge Medical Systems Israel, Functional Imaging
Published: 2022-12-19
License: https://open.fda.gov/license/

GE Medical Systems Israel, Functional Imaging / initiated 2022-12-19 / Open, Classified / root cause: manufacturing process

FDA source

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING began a recall of GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM... on 2022-12-19. FDA classified it as Class I and gives the reason as "A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury". 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-1056-2023
Classification: Class I
Status: Open, Classified
Initiated: 2022-12-19
Posted: 2023-02-08
Recalling firm: GE Medical Systems Israel, Functional Imaging
Product: GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM Gantry 3/8 inch, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640 X 3/8 inch; Emission Computed Tomography System
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: GE Healthcare issue an URGENT MEDICAL DEVICE CORRECTION on 12/19/2022 by mail. The notice explained the issue and the risk, and requested the following action by taken: .GE Healthcare asks that you STOP USE of your Nuclear Medicine system, if your system is listed in the Affected Product Details and Appendix of this letter, until an inspection of your system is completed by GE Healthcare and you have been provided with a letter indicating the system can be returned to clinical use. .GE Healthcare will correct all affected products at no cost to you. GE Healthcare will inspect your system to ensure that the appropriate mitigation is correctly implemented to address this potential life-threatening concern. A GE Healthcare representative will contact you to arrange for this correction. .If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 34 units
Distribution: Worldwide distribution. US nationwide including Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uzbekistan, and Vietnam.
Product codes and lots: a) OPTIMA O640X3/8 inch NR: Catalog number 5376204-41, UDI/DI Not Applicable, Serial Numbers: 64GY51002, 64GY51003, 64GY51004, 0000064GY51011, 64GY51005; b) DISCOVERY O640X 3/8 inch: Catalog number H3101RL, UDI/DI Not Applicable, Serial Numbers: 64GY51021; c) NM OPTIMA O640X3/8 inch: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 26043; d) O640 NM Gantry 3/8 inch: Catalog number 5376204-41, UDI/DI Not Applicable, Serial Numbers: 64GY51022; , UDI/DI Not Applicable, Serial Numbers: 64GY51024, 64GY51007, 64GY51019, 64GY51018, 64GY51016, 64GX51001, 64GY51006, 64GY51013, 64GZ51026, 64GY51025, 64GY51012, 64GY51023, 64GY51014, 64GZ51027; UDI/DI To be provided, Serial Numbers: 64GY51008, 64GY51009, 64GY51020, 64GZ51028, 64GZ51030, 64GY51015, 64GY51011; e) O640 NM GANTRY FINAL ASSY: Catalog number H3100JZ, UDI/DI To be provided, Serial Numbers: ONMX26515; f) OPTIMA O640X3/8 inch: Catalog number H3101RL, UDI/DI Not Applicable, Serial Numbers: 64GZ51029, 64GZ51031; Catalog number 5376204-41, UDI/DI Not Applicable, Serial Numbers: 64GY51017; UDI/DI To be provided, Serial Numbers: 64GY51010.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1056-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1053-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-08
Z-1054-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-08
Z-1055-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-08
Z-1056-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-08
Z-1057-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-08
Z-1058-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-08

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)