FDA Medical Device Recalls (openFDA)
Philips And Neusoft Medical Systems Co., Ltd.: NeuViz Dual series computed Tomography Scanner System, X-Ray System
- Recall number
- Z-2307-2008
- Recalling firm
- Philips And Neusoft Medical Systems Co., Ltd.
- Product
- NeuViz Dual series computed Tomography Scanner System, X-Ray System
- Status
- Terminated
- Initiated
- 2008-06-23
- Posted
- 2008-09-17
- Terminated
- 2010-09-24
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 15 units in US
- Distribution
- The units were distributed to one distributor in NC, and further distributed to medical facilities located in CO, FL, KY, NC, SC, TN and TX.
- Lot, serial or model codes
- Serial numbers 400562, 400563, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, and NDH034EI
- 510(k) numbers
- K062451, K071308
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3003575350
- Firm city
- Shenyang
- Firm state
- Liaoning
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28