NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner
FDA device recall Z-0001-2009 · posted 2009-01-26 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- An issue associated with the "Timed Scan" application was found. The system does not wait for the programmed time interval and starts the x-ray after selection of the scan button when certain criteria is met.
- Action taken
- A letter was issued to customers prior to the release of the field correction during June 2008. The system software will be updated to correct the non-compliances. For information or support concerning this issue, please contact the Neusoft Medical Systems Service Support Department (helpdesk@pnms.neusoft.com) or contact Philips Medical Systems North America Co. Phillips at 425-487-7602.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 19 units in the US.
- Distribution
- Nationwide Distribution --- USA including states of CO, FL, GA, IL, KY, NC, TN and TX.
- Date initiated
- 2008-04-10
- Date posted
- 2009-01-26
- Date terminated
- 2010-10-29
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM (K071308) | Neusoft Medical Systems Co., Ltd. | 2007-08-16 |
| NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM (K062451) | Neusoft Medical Systems Co., Ltd. | 2006-09-28 |