Recall Z-1573-2016— Philips and Neusoft Medical Systems Co., Ltd.

Name: FDA recall Z-1573-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-24

Class II · Terminated

Class II FDA medical device recall by Philips and Neusoft Medical Systems Co., Ltd., initiated 2016-03-24, terminated 2016-11-23. It names 2 FDA 510(k) clearances: K092742, K090173. 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: 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.

Recalling firm: Philips and Neusoft Medical Systems Co., Ltd.
Classification: Class II
Status: Terminated
Initiated: 2016-03-24
Terminated: 2016-11-23
Firm location: Shenyang, N/A, China

510(k) clearances named in this recall

2 on FDA's record

K092742 — NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEMNeusoft Medical Systems Co., Ltd.·cleared 2009-09-22
K090173 — NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEMNeusoft Medical Systems Co., Ltd.·cleared 2009-02-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.