FDAClass IIJanuary 20, 2021

GE NM/CT 870 CZT system recall

GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope…

Why was GE NM/CT 870 CZT system 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial numbers: 87CY63028, 87CZ63044, 87CZ63045, 87CZ63042, 87CY63025, 87CY63029, 87CY63027, 87CY63030, 87CZ63046, 87CY63034, 87CY63032, 87CY63033

Product
GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope…
Recalling firm
GE Healthcare, LLC
Quantity
12 units
Distribution
Worldwide
Recall date
January 20, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls