|
|
|
Product Description
|
Recall Class
|
FDA Recall Posting Date
|
Recalling Firm
|
|
Z-1204-2026 - Evolution Upgrade 1.5T.
Product Codes (REF): (1) 782148, (2) 782116.
MR systems with SW version R11.1 and R12.1.
|
2
|
01/29/2026
|
Philips North America
|
|
Z-1205-2026 - Evolution Upgrade 3.0T.
Product Code (REF): 782143.
MR systems with SW version R11.1 and R12.1.
|
2
|
01/29/2026
|
Philips North America
|
|
Z-1206-2026 - Ingenia 1.5T.
Product Code (REF): (1) 781341, (2) 781396.
MR systems with SW version R11.1 and R12.1.
|
2
|
01/29/2026
|
Philips North America
|
|
Z-1207-2026 - Ingenia 3.0T.
Product Code (REF): (1) 781342, (2) 781377.
MR systems with SW version R11.1 and R12.1.
|
2
|
01/29/2026
|
Philips North America
|
|
Z-1208-2026 - Ingenia 3.0T CX.
Product Code (REF): 781271.
MR systems with SW version R11.1 and R12.1.
|
2
|
01/29/2026
|
Philips North America
|
|
Z-1209-2026 - Ingenia Ambition S.
Product Code (REF): 782108.
MR systems with SW version R11.1 and R12.1.
|
2
|
01/29/2026
|
Philips North America
|
|
Z-1216-2026 - SmartPath to dStream for XR and 3.0T.
Product Code (REF): 781270.
MR systems with SW version R11.1 and R12.1.
|
2
|
01/29/2026
|
Philips North America
|
|
Z-1211-2026 - Ingenia Elition S.
Product Code (REF): (1) 781357, (2) 782106, (3)782137.
MR systems with SW version R11.1 and R12.1.
|
2
|
01/29/2026
|
Philips North America
|
|
Z-1212-2026 - Ingenia Elition X.
Product Code (REF): (1) 781358, (2) 782107, (3) 782136.
MR systems with SW version R11.1 and R12.1.
|
2
|
01/29/2026
|
Philips North America
|
|
Z-1213-2026 - MR 7700.
Product Code (REF): (1) 782120, (2) 782153.
MR systems with SW version R11.1 and R12.1.
|
2
|
01/29/2026
|
Philips North America
|