Recall Z-1793-2013— GE Healthcare, LLC

Name: FDA recall Z-1793-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-13

Class I · Terminated

Class I FDA medical device recall by GE Healthcare, LLC, initiated 2013-06-13, terminated 2014-06-19. It names one FDA 510(k) clearance: K121019. Product: Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies. Reason: GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re.

Recalling firm: GE Healthcare, LLC
Classification: Class I
Status: Terminated
Initiated: 2013-06-13
Terminated: 2014-06-19
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K121019 — OPTIMA NM/CT 640GE Healthcare·cleared 2012-04-19

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

Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies

Reason for recall

GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re

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