FDA-Device2017-04-12Class II

Mobile Diagnostic X-Ray System with Digital Panel

Philips Healthcare Inc.
Hazard

When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image.

Sold states
Nationwide (AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, MD, MI, MN, NC, NM, NY, OH, OR, PA, SC, TX, VT, WI)
Affected count
220 systems
Manufactured in
3000 Minuteman Road, N/A, Andover, MA, United States
Products
Mobile Diagnostic X-Ray System with Digital Panel

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1706-2017

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