Recalls / —

—#185056

Product

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.

FDA product code

KPS — System, Tomography, Computed, Emission

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K111445

Affected 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

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

GE Healthcare, LLC

Address

3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern

Worldwide

Timeline

Recall initiated

2020-12-10

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #185056. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.