Z-3242-2026Class II

MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade)

Name: Z-3242-2026 MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade)
Creator: Philips North America Llc
Published: 2026-08-21
License: https://open.fda.gov/license/

Philips North America Llc / initiated 2026-08-21 / Open, Classified

FDA source

Recall record

Recall number: Z-3242-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-21
Posted: 2026-09-18
Recalling firm: Philips North America Llc
Product: MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
FDA root cause: Software design
Action: On August 24, 2026 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: " To prevent this issue from occurring, o Use the standard 3D Vane scan protocol from the Philips Examcard Database, or o For custom 3D Vane scan protocols, use a maximum of 480 for the reconstruction matrix and use a maximum of 167 for the number of slices. " You may continue to use affected systems in accordance with their intended use. " Circulate this notice to all users or new owners of this device so that they are aware of the issues and associated hazard/harm. " Please retain this Urgent Medical Device letter with your system(s) until the software upgrade is installed; ensure the notice is in a place likely to be seen/viewed. Actions planned by Philips to correct the problem A Philips representative will contact you to schedule time for a Field Service Engineer (FSE) to install a software upgrade to resolve the issue (reference 2026-PD-MR-006).
Quantity in commerce: 37
Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;
Product codes and lots: 1. Model Number (REF): 782120; UDI-DI: 884838104112; Serial Numbers: 65002, 65003, 65014, 65015, 65050, 65029, 65056, 65018, 65021, 65035, 65038, 65000, 65025, 65006, 65008, 65043; 2. Model Number (REF): 782153; UDI-DI: 884838112858; Serial Numbers: 68011, 68022, 68031, 68014, 68012, 68009, 68033, 68053, 68023; 3. Model Number (REF): 782130; UDI-DI: 884838104402; Serial Numbers: 45007, 45052, 45043, 45044, 45552, 71616, 42164, 42066, 42104, 42248, 45263, 71532;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3242-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3232-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18
Z-3233-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18
Z-3234-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18
Z-3235-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18
Z-3236-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18
Z-3237-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18
Z-3238-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18
Z-3239-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18
Z-3240-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18
Z-3241-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18
Z-3242-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18
Z-3243-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18

Product code LNH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-23. View this recall on fda.gov (opens on fda.gov)