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.
- Company
- Ge Healthcare, Llc
- Recall Initiated
- December 10, 2020
- Recall Number
- Z-0856-2021
- Quantity
- 81 units
- Firm Location
- Waukesha, WI
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
Worldwide
Lot / Code Info
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
Root Cause
Process control
Action Taken
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.