Safety Alert for Infinia nuclear medicine systems; VG and VG Hawkeye nuclear medicine systems; Helix nuclear medicine systems; Brivo NM615; Discovery NM630; Optima NM/CT640; and Discovery NM/CT 670

Safety alert

2013-07-05

2013-07-05

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130705c.html

Medical device safety alert: ge healthcare nuclear medicine systems it has come to our attention that medical device manufacturer, ge healthcare has initiated a field safety corrective action concerning its nuclear medicine systems. the affected products are 1) infinia nuclear medicine systems; 2) vg and vg hawkeye nuclear medicine systems; 3) helix nuclear medicine systems; 4) brivo nm615; 5) discovery nm630; 6) optima nm/ct640; and 7) discovery nm/ct 670. on 5 june 2013, ge healthcare became aware of an incident in the united states that a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 due to a portion of the system falling onto the patient during the scan. investigation by the manufacturer found that bolts securing the camera to the gantry were loose, thereby stressing the support mechanism and resulting in the incident. because of the similarities in the design of support mechanisms across many products, the manufacturer has included all types and manufacturing dates of infinia and infinia hawkeye nuclear medicine systems; all types and manufacturing dates of vg and vg hawkeye nuclear medicine systems; and all types and manufacturing dates of helix nuclear medicine systems by elscint ltd. the manufacturer stated that the issue should also affected brivo nm615, discovery nm630, optima nm/ct640, discovery nm/ct670 due to similarities in basic mechanical concepts between these devices and the infinia systems. ge healthcare will inspect all affected systems to verify that the support mechanism fasteners are secured properly. furthermore, ge healthcare recommends that users to cease use of their nuclear medicine system until ge healthcare can complete an inspection of their system. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions. posted on 05 july 2013.