NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuVi
FDA device recall Z-1166-2013 · posted 2013-04-23 · Terminated
Recall details
- Recalling firm
- Philips And Neusoft Medical Systems Co., Ltd.
- 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.
- Action taken
- The firm, Neusoft Medical Systems Co., Ltd., sent an "URGENT DEVICE CORRECTION" NeuViz Dual and NeuViz 16 letter, dated Mar. 4, 2013, to their US consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to review this information with all members of their staff and retain a copy of the letter with the equipment Instruction For Use. Customers with questions should contact the Service Support Department by email to nms-service@neusoft.com
- Root cause
- Use error
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 25 units
- Distribution
- Nationwide distribution: USA including states of: California, Connecticut, North Carolina, Nebraska, Ohio, South Carolina, Texas, and Puerto Rico.
- Date initiated
- 2013-03-04
- Date posted
- 2013-04-23
- Date terminated
- 2013-11-22
- Location
- Shenyang, Liaoning, China
Monitor recalls programmatically
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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 |