NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body… — Class II medical device recall Z-1573-2016
Terminated recall by Philips and Neusoft Medical Systems Co., Ltd., reported 2016-05-04, distributed in CT, FL, LA, MO, NC, NE, OH, PR…. The following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version 1.1.4.21426:
| Recall number | Z-1573-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips and Neusoft Medical Systems Co., Ltd., Shenyang, N/A, China |
| Recall initiated | 2016-03-24 |
| Classified | 2016-04-27 |
| Reported by FDA | 2016-05-04 |
| Terminated | 2016-11-23 |
| Distributed | CT, FL, LA, MO, NC, NE, OH, PR, SC, TX |
| Quantity | 37 units |
| Reason classes | software, unapproved product |
| Serial numbers | N16E090002, N16E090003, N16E090007, N16E090008, N16E090010, N16E100017, N16E100023, N16E110023, N16E110026, N16E120016, N16E120023, N16E120052, N16E120053, N16E130012, N16E130038, N16E130045, N16E140007, N16E140008, N16E140012, N16E140017, N16E140020, N16E140029, N16E140030, N16E140031, N16E140056 and 12 more |
Product
NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 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.
Reason for recall
The following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version 1.1.4.21426: 1) During the filming operation on MX 16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patient's images before pasting, a previous patient's image may be present in the clipboard and be
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1573-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.