Z-1211-2026Class II

Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1...

Name: Z-1211-2026 Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1...
Creator: Philips North America
Published: 2025-12-03
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2025-12-03 / Open, Classified / root cause: software

FDA source

Philips North America began a recall of Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1 on 2025-12-03. FDA classified it as Class II and gives the reason as "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1211-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-03
Posted: 2026-01-29
Recalling firm: Philips North America LLC
Product: Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Root cause tag: software
FDA root cause: Software design
Action: Philips began notification of consignees on about 12/03/2025 via mailed Urgent Medical Device Correction letter, with a corrected notification sent on about 12/18/2025. Consignees were instructed to identify if any affected units were on hand, that the systems could continue to be use in accordance with their intended use. They were asked to provide the notification to all users of the device for awareness, maintain the Urgent Medical Device Correction letter with affected systems until the software upgrade is installed, and complete and return the provided response form. A Philips representative will contact each consignee to schedule time for a Field Service Engineer (FSE) to install a software upgrade to resolve the issues beginning in January 2026 (reference FCO78100585, FCO78100620).
Quantity in commerce: 5 units
Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.
Product codes and lots: MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781357; UDI-DI: 00884838088108; Serial Numbers: 46002. (2) Product Code (REF): 782106; UDI-DI: 00884838098329; Serial Numbers: 46243, 46292. (3) Product Code (REF): 782137; UDI-DI: 00884838108615; Serial Numbers: 64034, 64045.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1211-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1204-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-29
Z-1205-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-29
Z-1206-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-29
Z-1207-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-29
Z-1208-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-29
Z-1209-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-29
Z-1210-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-29
Z-1211-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-29
Z-1212-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-29
Z-1213-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-29
Z-1214-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-29
Z-1215-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-29
Z-1216-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-29

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 2026-09-05. View this recall on fda.gov (opens on fda.gov)