Philips Intera 1.5T MRI Systems Recalled for Software Issue
Philips is recalling 82 Intera 1.5T MRI systems worldwide because a software issue can terminate examinations during image reconstruction if specific scan parameters are manually adjusted.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no hospitalizations or serious injuries are reported. The issue is a software defect that terminates examinations, which is a functional failure rather than a direct physical hazard like fire or shock.
Plain-English summary
Philips North America LLC is recalling 82 units of Intera 1.5T MRI systems, including various models such as the Intera 1.5T, Intera 1.5T Achieva IT Nova, and Intera Achieva 1.5T Pulsar. The affected units are distributed worldwide, including in the United States and numerous other countries.
The recall is due to a software issue that will terminate an examination during the image reconstruction process if scan parameters are manually adjusted in a way that causes reconstruction requirements to exceed the available system memory. This issue affects the specific model numbers and serial numbers listed in the recall documentation.
Healthcare facilities and users of these MRI systems should contact Philips North America LLC for instructions on how to resolve the software issue. The recall is classified as Class II by the FDA, indicating that the defect could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera 1.5T Achieva Nova-Dual (781173), 6. Intera 1.5T Omni/Stellar (781104), 7. Intera Achieva 1.5T Pulsar (781171);
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI Systems
- Hazard
- Affected units
- 82
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1. Intera 1.5T Model Numbers (REF): 781195
- UDI-DI: N/A
- Serial Numbers: 18774
- 18781
- 18951
- 18958
- 18962
- 18971
- 20431
- 18898
- 20429
- 18669
- 18981
- 18982
- 18734
- 18763
- 20427
- 18842
- 18654
- 18878
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Philips North America Llc
See all →- ModeratePhilips Achieva XR MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
- ModeratePhilips MR 5300 MRI Scanner Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
- ModeratePhilips MR 7700 MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
Same hazard · software defect
See all →- ModeratePhilips Achieva 3.0T MRI Software Recall for Memory Limit Issues
FDA (Devices) · 2026-09-30
- HighAbiomed Recalls Automated Impella Controllers Due to Firmware and Software Defects
FDA (Devices) · 2026-09-30
Similar recalls
- ModeratePhilips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips Achieva 3.0T MRI Software Recall for Memory Limit Issues
FDA (Devices) · 2026-09-30
- ModerateIngenia 1.5T MRI Systems Recalled for Alignment Errors
FDA (Devices) · 2025-05-28
- ModeratePhilips Ingenia MRI Software Recall for Memory-Related Scan Termination
FDA (Devices) · 2026-09-30
- ModeratePhilips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
- HighPhilips Intera 1.5T MRI Systems Recalled for Helium Gas Risk
FDA (Devices) · 2018-04-25