PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 8, 2019 Initiated: March 20, 2019 #Z-1266-2019

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

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.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
35 units
Distribution
US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by GE Healthcare, LLC. Units affected: 35 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 8, 2019. Severity: Moderate. Recall number: Z-1266-2019.

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