Recall Z-1166-2013— Philips And Neusoft Medical Systems Co., Ltd.
Class II · Terminated
Class II FDA medical device recall by Philips And Neusoft Medical Systems Co., Ltd., initiated 2013-03-04, terminated 2013-11-22. It names one FDA 510(k) clearance: K071308. Product: NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.. Reason: User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel..
- Recalling firm
- Philips And Neusoft Medical Systems Co., Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-04
- Terminated
- 2013-11-22
- Firm location
- Shenyang, Liaoning, China
510(k) clearances named in this recall
1 on FDA's recordK-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
NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.
Reason for recall
User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.
Data sourced from openFDA. This site is unofficial and independent of the FDA.