Recall – Outdated tomography system software causes injury

Company: GE Healthcare, LLC
Date of Enforcement Report: 6/10/2020
Class II

PRODUCT

System, Tomography Computed Emmission

Recall Number: Z-2258-2020

REASON

GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.

RECALLING FIRM/MANUFACTURER

GE Healthcare, LLC on 11/30/2018. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

526 total units

DISTRIBUTION

US Nationwide and International

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