Recall Z-0121-2013— GE Healthcare, LLC

Name: FDA recall Z-0121-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-12

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2012-10-12, terminated 2013-11-14. It names 2 FDA 510(k) clearances: K111445, K093514. Product: GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.. Reason: GE Healthcare has recently become aware of a potential safety issue associated with the table pallet of your Discovery NM/CT 670 and/or Discovery NM630 system which may impact operation safety. At scan setup, during gantry rotation towards scanning position, a potential contact between the table-pallet-edge and the detector was identified. Such occurrence may damage the pallet front-edge and.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2012-10-12
Terminated: 2013-11-14
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K111445 — DISCOVERY NM 630GE Healthcare·cleared 2011-06-03
K093514 — DISCOVERY MODEL NM/CT 670Ge Medical Systems F.I. Haifa·cleared 2009-12-10

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 Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.

Reason for recall

GE Healthcare has recently become aware of a potential safety issue associated with the table pallet of your Discovery NM/CT 670 and/or Discovery NM630 system which may impact operation safety. At scan setup, during gantry rotation towards scanning position, a potential contact between the table-pallet-edge and the detector was identified. Such occurrence may damage the pallet front-edge and

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