Recall Z-2237-2010 ยท JAK System, X-Ray, Tomography, Computed
Neuisys, LLC
NeuViz Dual series Computed Tomography (CT) Scanner System, X-Ray System. Part Number: 989605651321. Intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.
| Date | Aug 19, 2010 (initiated Jul 21, 2008) |
| Status | Terminated |
| Reason | The reference lines for image generated for a Surview scan may appear in the incorrect position in the "FILM" display mode. |
| Root cause | Software design |
| Action | On 07/21/2008, NEUISYS Imaging Systems Solutions distributor in Greensboro, NC began sending the URGENT DEVICE CORRECTION letter on behalf of Philips and NeuSoft Medical Systems (PNMS), Co., Ltd in China. The letter informs the consignees that there is potential safety problem in the NeuViz Dual series CT scanners due to the malfunction of "Incorrect Reference Line in the Film". When a "Head first, Couch out" or a "Feet first, Couch in" Surview scan is started then paused midstream, the image generated is what the doctor expects, but the reference lines appear in the incorrect position in " |
| Quantity | 19 units in the US |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |