PlainRecalls
FDA Devices Moderate Class II Terminated

NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for 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. The main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table, Remote Control Unit and NM operation con

Reported: May 8, 2019 Initiated: March 20, 2019 #Z-1261-2019

Product Description

NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for 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. The main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table, Remote Control Unit and NM operation console.

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
37 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? ▼
NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for 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. The main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table, Remote Control Unit and NM operation console.. Recalled by GE Healthcare, LLC. Units affected: 37 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-1261-2019.

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