FDAClass IIAugust 1, 2012

NeuViz 16 Multi-Slice CT Scanner System is a computed recall

NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part…

Why was NeuViz 16 Multi-Slice CT Scanner System is a computed recalled?

One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner, which caused the Oil-accumulator to detach.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial No.: N16E0 90002, N16E0 90003, N16E0 90004, N16E0 90007, N16E0 90008, N16E0 90010, N16E1 00015, N16E1 00017, N16E1 00023, N16E1 10016, N16E1 10023, N16E1 10026, N16E1 10027, N16E1 10040, and N16E1 10053.

Product
NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part…
Recalling firm
Philips And Neusoft Medical Systems Co., Ltd.
Quantity
15 units distributed in the US
Distribution
Nationwide Distribution -- North Carolina, Ohio, and Texas.
Recall date
August 1, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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