FDA-Device2025-05-28Class II

Product Name: Upgrade to MR 7700; Model Number: 782130;

Philips North America Llc
Hazard

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Sold states
Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.
Affected count
13 units (7 US, 6 OUS)
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Product Name: Upgrade to MR 7700; Model Number: 782130;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1792-2025

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