Recall Z-2803-2015— GE Healthcare

Name: FDA recall Z-2803-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-17

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, initiated 2015-07-17, terminated 2016-03-08. It names one FDA 510(k) clearance: K041543. Product: PET Discovery ST 16. Reason: Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner..

Recalling firm: GE Healthcare
Classification: Class II
Status: Terminated
Initiated: 2015-07-17
Terminated: 2016-03-08
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K041543 — GE DISCOVERY STGE Healthcare·cleared 2004-06-22

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

PET Discovery ST 16

Reason for recall

Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.

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