Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a dia...
FDA Device Recall #Z-2412-2021 — Class II — August 11, 2021
Recall Summary
| Recall Number | Z-2412-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 11, 2021 |
| Status | Completed |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips North America Llc |
| Location | Cambridge, MA |
| Product Type | Devices |
| Quantity | 42 units |
Product Description
Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781315
Reason for Recall
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.
Lot / Code Information
Model: 78135 Serial Number Unique Device Identifier (UDI#) 61019 (01)00884838099715 61028 (01)00884838099715 61001 (01)00884838099715 61004 (01)00884838099715 61023 (01)00884838099715 61008 (01)00884838099715 61026 (01)00884838099715 61034 (01)00884838099715 61046 (01)00884838099715 61025 (01)00884838099715 61035 (01)00884838099715 61042 (01)00884838099715 61040 (01)00884838099715 61041 (01)00884838099715(21)61041 61007 (01)00884838099715 61014 (01)00884838099715 61018 (01)00884838099715 61000 N/A 61003 (01)00884838099715 61002 N/A 61006 N/A 61009 N/A 61013 N/A 61017 (01)00884838099715(21)61017 61032 (01)00884838099715(21)61032 61015 N/A 61005 (01)00884838099715 61020 (01)00884838099715 61043 (01)00884838099715 61029 (01)00884838099715 61030 (01)00884838099715 61033 (01)00884838099715(21)61033 61052 (01)00884838099715(21)61052 61064 (01)00884838099715(21)61064 61027 (01)00884838099715 61016 (01)00884838099715 61022 (01)00884838099715 61044 (01)00884838099715 61050 (01)00884838099715 61047 (01)00884838099715(21)61047 61053 (01)00884838099715(21)61053 61049 (01)00884838099715(21)61049
Other Recalls from Philips North America Llc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1316-2026 | Class II | IQon Spectral CT; Product Code (REF): 728332; | Jan 7, 2026 |
| Z-1318-2026 | Class II | Spectral CT 7500 on Rails; Product Code (REF):... | Jan 7, 2026 |
| Z-1317-2026 | Class II | Spectral CT; Product Code (REF): 728333; | Jan 7, 2026 |
| Z-1315-2026 | Class II | Brilliance iCT; Product Code (REF): 728306; | Jan 7, 2026 |
| Z-1033-2026 | Class II | Philips Smart-hopping 2.0 AP 1.4 GHz. Patient M... | Dec 12, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.