Philips And Neusoft Medical Systems Co., Ltd. NeuViz Dual series computed Tomography Scanner System, X-Ray System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NeuViz Dual series computed Tomography Scanner System, X-Ray System
Brand
Philips And Neusoft Medical Systems Co., Ltd.
Lot Codes / Batch Numbers
Serial numbers 400562, 400563, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, and NDH034EI
Products Sold
Serial numbers 400562, 400563, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, and NDH034EI
Philips And Neusoft Medical Systems Co., Ltd. is recalling NeuViz Dual series computed Tomography Scanner System, X-Ray System due to Potential for R-host box and components inside to be detached of its mounting during the gantry rotor rotation. There is a potential for components t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for R-host box and components inside to be detached of its mounting during the gantry rotor rotation. There is a potential for components to be damaged inside the system gantry and for the internal components to be expelled from the system gantry and injure the patient, operator, bystander or service people.
Recommended Action
Per FDA guidance
On 6/23/08/08, the Philips Neusoft sent a letter dated 6/10/08 to their US customers explaining the problem, under what circumstances it can occur, and the actions that should be taken by the customer/user in order to prevent risks for patients or users. The field correction is install a R-host bracket to aid supporting of the R-host computer. The letter included additional information to customers who had already received the field action (this was an on-going activity that was re-classified as a potential safety). Customers did not receive the additional information about the status of their upgrade if the upgrade had not occurred at the time of the mailing. They were informed that they would be contacted by Newsoft Medical systems representative for the planning of this repair. If you have questions contact Service Support Department at nms-service@neusoft.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, FL, IN, KY, NC, SC, TN, TX
Page updated: Jan 10, 2026