NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a conti
FDA device recall Z-1573-2016 · posted 2016-04-27 · Terminated
Recall details
- Recalling firm
- Philips and Neusoft Medical Systems Co., Ltd.
- 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
- Action taken
- Affected consignees will be notified of the recall via letter on March 24, 2016. Mandatory Field Change Order and FCO kits will be released to all affected systems in June, 2016.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 37 units
- Distribution
- NC, OH, NE, SC, TX, LA, PR, MO, FL, CT
- Date initiated
- 2016-03-24
- Date posted
- 2016-04-27
- Date terminated
- 2016-11-23
- Location
- Sujiatun Shenyang, China
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM (K092742) | Neusoft Medical Systems Co., Ltd. | 2009-09-22 |
| NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM (K090173) | Neusoft Medical Systems Co., Ltd. | 2009-02-05 |