FDA Medical devices recall ·
Upgrade to MR 7700 recall
- Recall number
- Z-1792-2025
- Date
- (initiated May 13, 2025)
- Company / brand
- Philips North America Llc
222 Jacobs St, Cambridge, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 13 units (7 US, 6 OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Product Name: Upgrade to MR 7700; Model Number: 782130;
Why was it recalled?
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 782130; UDI-DI: 00884838104402; Serial Numbers: 42030, 42066, 42151, 42211, 42248, 42376, 45001, 45007, 45236, 71613, 71907, 85643, 85644;
Distribution
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.
States: Georgia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1792-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.