Z-1056-2023 Class I Ongoing
Recalled by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
— Tirat Carmel
FDA device recall Z-1056-2023 was initiated by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING on Dec 19, 2022 and is designated Class I. 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. The recall status is ongoing. Affected quantity: 34 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 15, 2023
- Initiation Date
- Dec 19, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34 units
Product Description
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
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 Pattern
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.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1056-2023
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026
These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.