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