Philips Medical Systems Recall: Ingenuity Core Model Number 728321 Product Usage: Computed
Philips Medical Systems Recall: Ingenuity Core Model Number 728321 Product Usage: Computed is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Philips Medical Systems; Product: Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sec
| Recalling firm | Philips Medical Systems |
|---|---|
| Product | Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. |
| Reason for recall | The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to s |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - US Nationwide in the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, GA, IA, IL, IN, FL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NH, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY. and the countries of Algeria, Argentina, Australia, Bang |
| Recall initiated | 20160824 |
| Recall number | Z-0010-2017 |
| Category | device |
| State | OH |
| Country | United States |
$29/mo
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