Z-0856-2021 Class II Terminated
FDA device recall Z-0856-2021 was initiated by GE Healthcare, LLC on December 10, 2020 and is designated Class II. 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. The recall status is terminated (terminated August 21, 2026). Affected quantity: 81 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 20, 2021
- Initiation Date
- December 10, 2020
- Termination Date
- August 21, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 81 units
Product Description
Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
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.
Distribution Pattern
Worldwide
Code Information
Discovery NM 630 (Model Number H3101RH), Serial numbers: 63GY50110, 63GY50119, 63GY50116, 63GZ50141, 63GY50120, 63GY50108, 63GY50121, 63GZ50142, 63GY50112, 63GZ50139, 63GY50107, 63GZ50138 NM 830 (Model Number H3910AC), Serial Numbers: 830Z60199, 830Z60182, 830Z60183, 830Z60192, 830Y60089, 830Y60105, 830Y60079, 830Z60207, 830Y60092, 830Y60102, 830Y60081, 830Z60200, 830Y60106, 830Z60201, 83EZ88001, 830Y60111, 830Y60094, 830Z60211, 830Y60101, 830Z60210, 830Y60118, 830Z60195, 830Z60194, 830Z60198, 830Z60181, 830Z60202, 830Y60097, 830Z60196, 830Z60180, 830Y60078, 830Y60115, 830Y60114, 830Y60108, 830Y60100, 830Y60087, 830Y60084, 830Z60188, 830Z60206, 830Y60112, 830Y60082, 830Y60093, 830Z60191, 830Y60107, 830Y60080, 830Z60190, 830Y60103, 830Z60193, 830Y60095, 830Y60119, 830Z60209, 830Z60205, 830Y60073, 830Y60120, 830Y60083, 830Y60116, 830Z60203, 830Y60085, 830Y60077, 830Z60184, 830Y60086, 830Z60187, 830Y60113, 830Z60208, 830Y60110, 830Z60204, 830Y60072, 830Z60179, 830Z60186 830 NM Cyber Defense (Model Number H3910AG), Serial Numbers: 830Z60185