FDA Medical Device Recalls (openFDA)
Philips And Neusoft Medical Systems Co., Ltd.: NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
- Recall number
- Z-0466-2013
- Recalling firm
- Philips And Neusoft Medical Systems Co., Ltd.
- Product
- NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
- Status
- Terminated
- Initiated
- 2012-10-18
- Posted
- 2012-12-04
- Terminated
- 2013-07-08
- Reason
- The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners.
- Root cause
- Device Design
- Action
- Philips and Neusoft Medical Systems Co., Ltd. sent an Urgent Device Correction NeuViz Dual, NeuViz 16 letter, dated Oct. 18, 2012, to all affected US customers and distributors. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to: 1. Have a mechanic check the patient table top screws fixing. Detailed instructions are attached as Annex with the letter. 2. If it is found that table top screws are improperly assembled, stop using the product and contact local Service personnel for repair. Philips and Neusoft Medical Systems Co., Ltd is in the process of upgrading devices with aforementioned kits and will contact customers to arrange for an update to affected systems. If you have any questions about this corrective action program, please contact the Service Support Department, Neusoft Medical Systems Co. Ltd. at nms-service@neusoft.com For questions regarding this recall call 425-487-7665.
- Quantity
- 20 units of NeuViz 16 CT Scanner Systems and 25 units of NeuViz Dual series
- Distribution
- Nationwide Distribution including North Carolina, Ohio, Texas, and Puerto Rico.
- Lot, serial or model codes
- NeuViz 16 system Serial numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120022, N16E120020, N16E120023, N16E120024. Neuviz Dual Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR090003, NDHR090012, and NDHR090013.
- 510(k) numbers
- ["K062451","K071308","K090173","K092742"]
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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