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Terminated

GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

FDA Recall Z-0855-2021 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeKPS
Date Initiated2020-12-10
Date Terminated2026-08-21
Product Quantity12 units

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.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K153402Discovery NM/CT 670 CZTGE Healthcare · 2016-01-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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