Recall Z-1257-2019— GE Healthcare, LLC

Name: FDA recall Z-1257-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-20

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2019-03-20, terminated 2020-10-05. It names one FDA 510(k) clearance: K111445. Product: Discovery NM 630 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: 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..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-03-20
Terminated: 2020-10-05
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K111445 — DISCOVERY NM 630GE Healthcare·cleared 2011-06-03

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

Discovery NM 630 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.

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