Recall Z-2259-2020— GE Healthcare, LLC

Name: FDA recall Z-2259-2020
Creator: U.S. Food and Drug Administration
Published: 2018-11-30

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2018-11-30. It names one FDA 510(k) clearance: K080124. Product: System, Tomography Computed Emmission. 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: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2018-11-30
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K080124 — VENTRI 1.1Ge Medical Systems F.I. Haifa·cleared 2008-01-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

System, Tomography Computed Emmission

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.