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
- Recall Initiated
- December 19, 2022
- Posted
- February 8, 2023
- Recall Number
- Z-1056-2023
- Quantity
- 34 units
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.
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.
Lot / Code Info
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.
Root Cause
Process control
Action Taken
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.