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GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine i...

FDA Recall #Z-0853-2021 — Class II — December 10, 2020

Recall #Z-0853-2021 Date: December 10, 2020 Classification: Class II Status: Ongoing

Product Description

GE NM/CT 850 system Model Number H3907AD - 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.

Recalling Firm

GE Healthcare, LLC — Waukesha, WI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

24 units

Distribution

Worldwide

Code Information

Serial numbers: 85EY67048, 850Y61018, 85EY67045, 85EY67046, 85EY67047, 850Z61038, 85EY67043, 850Z61042, 85EZ67056, 850Z61043, 850Z61044, 850Z61045, 850Z61041, 850Z61039, 850Z61040, 85EZ67055, 85EZ67053, 85EZ67054, 850Y61019, 85EY67044, 85EY67049, 85EZ67052, 85EY67050, 85EZ67051

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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