FDA-Device2016-11-30Class II
Philips Healthcare System X-ray Tomography Computed :
Philips Electronics North America Corporation
Hazard
It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.
Sold states
USA(nationwide) Distribution to the states of : AZ, NY, GA, UT, TN, TX, AR, NV, Il, FL, MS, LA, MD, MO, MA, OK, KY, WY, SC, ND, NE, DE, MI, WA, CT, RI, KS, OR, IN, PA, CA, NJ, NC, MN, AL and IA.
Affected count
1363
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Philips Healthcare System X-ray Tomography Computed :
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0376-2017Don't want to check this manually?
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