Recall Z-1745-2019— GE Healthcare, LLC

Name: FDA recall Z-1745-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-12

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2019-02-12. It names one FDA 510(k) clearance: K081496. Product: Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.. Reason: GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2019-02-12
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K081496 — OPTIMA PET/CT 560Ge Medical Systems, LLC·cleared 2008-06-12

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

Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

Reason for recall

GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure

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