Philips Medical Systems (Cleveland) Inc recalls Philips Ingenuity Core computed tomography x-ray system
- Recall date
- October 6, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0519-2018
- FDA classification
- Class II
- Brand / firm
- Philips Medical Systems (Cleveland) Inc
- Sold / distributed
- 26 US Govt accounts
Why it was recalled
Numerous issues related to software Brilliance iCT 4.1.6 software version.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Philips Ingenuity Core computed tomography x-ray system
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