NeuViz Dual series computed Tomography Scanner System, X-Ray System The CT scanner is a whole body x-ray computed tomogr
FDA device recall Z-2235-2008 · posted 2008-09-17 · Terminated
Recall details
- Recalling firm
- Philips And Neusoft Medical Systems Co., Ltd.
- Reason for recall
- Labeling of patient position on scanned image does not match actual patient orientation.
- Action taken
- On 12/17/08 the distributor sent a letter dated 12/13/07 to their customers explaining the problem and under what circumstances it can occur, the actions that should be taken by the customer/user in order to prevent risks for patients or users, and that the customer/user will be contacted for scheduling of a software upgrade by the distributor. Contact NEUISYS Service Support Department at 1-877-299-9052 for assistance.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 15 units
- Distribution
- Distribution in US: CO, FL, KY, NC, SC, TN, and TX.
- Date initiated
- 2007-12-17
- Date posted
- 2008-09-17
- Date terminated
- 2012-02-16
- Location
- Shenyang, Liaoning, China
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 |