Recall Z-2992-2020— GE Healthcare, LLC

Name: FDA recall Z-2992-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-14

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2020-08-14, terminated 2021-05-06. It names one FDA 510(k) clearance: K173816. Product: NM/CT 860, SPECT/CT. Reason: Rotor bearing screws were found loose on detector..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-08-14
Terminated: 2021-05-06
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K173816 — NM/CT 850, NM/CT 860GE Healthcare·cleared 2018-04-17

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

NM/CT 860, SPECT/CT

Reason for recall

Rotor bearing screws were found loose on detector.

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