NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is label...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2083-2012.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2083-2012.
Recall terminated by FDA.
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- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2083-2012.
Philips And Neusoft Medical Systems Co., Ltd.
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Philips And Neusoft Medical Systems Co., Ltd. Recall FAQ
Philips And Neusoft Medical Systems Co., Ltd. is the subject of a medical devices safety report: NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is label.... The notice was published on June 8, 2012 by the U.S. Food and Drug Administration (FDA). Approximately 15 units are potentially affected.