Recall Z-2241-2011 ยท JAK System, X-Ray, Tomography, Computed
Philips And Neusoft Medical Systems Co., Ltd.
NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".
| Date | May 23, 2011 (initiated Feb 9, 2011) |
| Status | Terminated |
| Reason | Dimension measurement displays on a combined image were found inaccurate after the clinician merged multiple image series into one image. |
| Root cause | Other |
| Action | 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 |
| Quantity | 9 units distributed in US |
| Distribution | Nationwide Distribution including CA, GA, LA, NC, OH, TN and TX. |
| FDA record | Open on fda.gov |