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.
FDA Recall Z-1266-2019 · Posted None
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeJAK
Date Initiated2019-03-20
Date Terminated2020-10-05
Product Quantity35 units
Reason for Recall
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.
Firm Action
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.
Root Cause
Device Design
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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