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Terminated

NeuViz Dual series computed Tomography Scanner System, X-Ray System The CT scanner is a whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle.

FDA Recall Z-2235-2008 · Posted 2008-09-17

Recalling FirmPhilips And Neusoft Medical Systems Co., Ltd.
Recall StatusTerminated
Product CodeJAK
Date Initiated2007-12-17
Date Terminated2012-02-16
Product Quantity15 units

Reason for Recall

Labeling of patient position on scanned image does not match actual patient orientation.

Firm Action

On 12/17/08 the distributor sent a letter dated 12/13/07 to their customers explaining the problem and under what circumstances it can occur, the actions that should be taken by the customer/user in order to prevent risks for patients or users, and that the customer/user will be contacted for scheduling of a software upgrade by the distributor. Contact NEUISYS Service Support Department at 1-877-299-9052 for assistance.

Root Cause

Software design

Distribution Pattern

Distribution in US: CO, FL, KY, NC, SC, TN, and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071308MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEMNeusoft Medical Systems Co., Ltd. · 2007-08-16K062451NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEMNeusoft Medical Systems Co., Ltd. · 2006-09-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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