NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The d
FDA device recall Z-2241-2011 · posted 2011-05-23 · Terminated
Recall details
- Recalling firm
- Philips And Neusoft Medical Systems Co., Ltd.
- Reason for recall
- Dimension measurement displays on a combined image were found inaccurate after the clinician merged multiple image series into one image.
- Action taken
- Neusoft Medical Systems sent an Urgent Device Correction Notification letter dated February 9, 2011, via certified mail to their distributor NEUISYS. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to discontinue use of combined images. Instead, use MPR Batch for diagnostic reviews until the planned upgrade is provided to the product. Neusoft Medical System and Philips Medical System released the mandatory Field Change Order (FCO) by March 31, 2011. All nine affected systems will be updated with aforementioned kits in six months after the release. Consignees were instructed to contact Service Support Department by e-mail to nms-service@neusoft.com
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 9 units distributed in US
- Distribution
- Nationwide Distribution including CA, GA, LA, NC, OH, TN and TX.
- Date initiated
- 2011-02-09
- Date posted
- 2011-05-23
- Date terminated
- 2011-08-24
- Location
- Shenyang, Liaoning, China
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM (K092742) | Neusoft Medical Systems Co., Ltd. | 2009-09-22 |
| NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM (K090173) | Neusoft Medical Systems Co., Ltd. | 2009-02-05 |