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Recall Observatory FDA recall evidence

Device product

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

Z-1792-2025

May 13, 2025

Class II

Product summary

Firm
Philips North America Llc
Event
Event 96889
Status
Ongoing
Classification
Class II
Quantity
13 units (7 US, 6 OUS)
Official record key
device-enforcement:Z-1792-2025

Official wording

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

Code information: Model Number: 782130; UDI-DI: 00884838104402; Serial Numbers: 42030, 42066, 42151, 42211, 42248, 42376, 45001, 45007, 45236, 71613, 71907, 85643, 85644;

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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