—#171919

Product

NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health 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

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K093514
Affected lot / code info: Mfg. Lot or Serial # System ID Model, Catalogue or Code # 870Y64037 SHIPPED (GON 4566933) H3100AS 870Y64040 SHIPPED (GON 4751375) H3100AS 870X64011 216844DR870 H3100AS 870X64024 802775D870 H3100AS 870X64002 206SCCANM H3100AS 870X64032 262741NUC H3100AS 870X64001 030020NU06 H3100AS 870Y64034 514345BD870 H3100AS 870Y64035 M54606132 H3100AS 870X64012 X634445001 H3100AS 870X64007 V2728113 H3100AS 870X64009 M4016255 H3100AS 870X64026 M40230109 H3100AS 870X64017 M40240121 H3100Q 870X64018 M40240122 H3100Q 870X64016 499221NU01 H3100AS 870X64022 A5173220 H3100AS NT3DG1800003BH NS0303 5376204-70-60-1 NT3DG1800002BH NS0302 5376204-70-60-1 870X64025 EMM0530 H3100AS 870Y64038 MST01300 H3100AS 870X64029 PL1031NM01 H3100AS 870X64027 PL0398NM01 H3100AS 870X64030 PL2190NM01 H3100AS 870X64028 PL0372NM01 H3100AS 870X64013 NP473631 H3100AS 870X64008 00669NUC03 H3100AS

Why it was recalled

During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.

Root cause (FDA determination)

Device Design

Action the firm took

GE Healthcare sent an Urgent Medical Device Correction letter dated March 20, 2019 to affected customers. The letter identified the affected product, problem and actions to be taken. GE Healthcare will inspect and, if required, correct all affected products at no cost to you to ensure that all design redundancies are in place. A GE Healthcare representative will contact you to arrange for the correction. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK

Timeline

Recall initiated: 2019-03-20
Terminated: 2020-10-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171919. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.