Recall Z-1546-2021— GE Healthcare, LLC

Name: FDA recall Z-1546-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-07

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2021-02-07. It names one FDA 510(k) clearance: K173816. Product: NM/CT 860 Nuclear Medicine / CT Scanners. Reason: GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2021-02-07
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 Nuclear Medicine / CT Scanners

Reason for recall

GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.

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