Recall Z-0024-2014— GE Healthcare, LLC

Name: FDA recall Z-0024-2014
Creator: U.S. Food and Drug Administration
Published: 2013-03-26

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2013-03-26, terminated 2013-12-05. It names one FDA 510(k) clearance: K081496. Product: GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.. Reason: GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-03-26
Terminated: 2013-12-05
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

GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.

Reason for recall

GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID

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