Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic ...
FDA Device Recall #Z-2413-2021 — Class II — August 11, 2021
Recall Summary
| Recall Number | Z-2413-2021 |
| 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 | 144 units |
Product Description
Ingenia 1.5T S-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: 781347
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: 78137 Serial Number Unique Device Identifier (UDI#) 81045 N/A 81075 (01)00884838068421(21)81075 81076 (01)00884838068421(21)81076 81077 (01)00884838068421(21)81077 81096 (01)00884838068421(21)81096 81124 (01)00884838068421(21)81124 81114 (01)00884838068421(21)81114 81126 (01)00884838068421(21)81126 81125 (01)00884838068421(21)81125 81144 (01)00884838068421(21)81144 81145 (01)00884838068421(21)81145 81159 (01)00884838068421(21)81159 81003 N/A 81111 (01)00884838068421(21)81111 81050 N/A 81051 (01)00884838068421(21)81051 81090 (01)00884838068421(21)81090 81021 N/A 81038 N/A 81185 (01)00884838068421(21)81185 81179 (01)00884838068421(21)81179 81005 N/A 81006 N/A 81011 N/A 81009 N/A 81019 N/A 81020 N/A 81016 N/A 81023 N/A 81017 N/A 81024 N/A 81014 N/A 81018 N/A 81004 N/A 81041 N/A 81057 (01)00884838068421(21)81057 81055 (01)00884838068421(21)81055 81037 (01)00884838068421(21)81037 81049 (01)00884838068421(21)81049 81060 (01)00884838068421(21)81060 81056 (01)00884838068421(21)81056 81064 (01)00884838068421(21)81064 81062 (01)00884838068421(21)81062 81070 (01)00884838068421(21)81070 81078 (01)00884838068421(21)81078 81073 (01)00884838068421(21)81073 81074 (01)00884838068421(21)81074 81112 (01)00884838068421(21)81112 81115 (01)00884838068421(21)81115 81122 (01)00884838068421(21)81122 81147 (01)00884838068421(21)81147 81146 (01)00884838068421(21)81146 81153 (01)00884838068421(21)81153 81156 (01)00884838068421(21)81156 81158 (01)00884838068421(21)81158 81093 (01)00884838068421(21)81093 81027 N/A 81035 N/A 81010 (01)00884838068421(21)81010 81063 (01)00884838068421(21)81063 81028 (01)00884838068421(21)81028 81030 (01)00884838068421(21)81030 81106 (01)00884838068421(21)81106 81052 N/A 81067 (01)00884838068421(21)81067 81105 (01)00884838068421(21)81105 81116 (01)00884838068421(21)81116 81013 N/A 81007 N/A 81008 N/A 81040 N/A 81031 (01)00884838068421(21)81031 81152 (01)00884838068421(21)81152 81044 N/A 81167 (01)00884838068421(21)81167 81170 (01)00884838068421(21)81170 81171 (01)00884838068421(21)81171 81047 (01)00884838068421(21)81047 81059 (01)00884838068421(21)81059 81108 (01)00884838068421(21)81108 81148 (01)00884838068421(21)81148 81133 (01)00884838068421(21)81133 81001 N/A 81086 (01)00884838068421(21)81086 81118 (01)00884838068421(21)81118 81139 (01)00884838068421(21)81139 81140 (01)00884838068421(21)81140 81138 (01)00884838068421(21)81138 81151 (01)00884838068421(21)81151 81175 N/A 81184 N/A 81079 (01)00884838068421(21)81079 81069 (01)00884838068421(21)81069 81061 (01)00884838068421(21)81061 81065 (01)00884838068421(21)81065 81098 (01)00884838068421(21)81098 81085 (01)00884838068421(21)81085 81092 (01)00884838068421(21)81092 81091 (01)00884838068421(21)81091 81032 N/A 81043 (01)00884838068421(21)81043 81026 N/A 81129 (01)00884838068421(21)81129 81131 (01)00884838068421(21)81131 81149 (01)00884838068421(21)81149 81155 (01)00884838068421(21)81155 81162 (01)00884838068421(21)81162 81172 (01)00884838068421(21)81172 81165 (01)00884838068421(21)81165 81180 (01)00884838068421(21)81180 81084 (01)00884838068421(21)81084 81087 (01)00884838068421(21)81087 81088 (01)00884838068421(21)81088 81095 (01)00884838068421(21)81095 81094 (01)00884838068421(21)81094 81100 (01)00884838068421(21)81100 81127 (01)00884838068421(21)81127 81132 (01)00884838068421(21)81132 81174 (01)00884838068421(21)81174 81039 N/A 81071 (01)00884838068421(21)81071 81157 (01)00884838068421(21)81157 81176 (01)00884838068421(21)81176 81117 (01)00884838068421(21)81117 81173 (01)00884838068421(21)81173 81025 N/A 81097 (01)00884838068421(21)81097 81154 (01)00884838068421(21)81154 81015 N/A 81029 N/A 81046 N/A 81033 N/A 81034 N/A 81048 N/A 81042 N/A 81058 (01)00884838068421(21)81058 81080 (01)00884838068421(21)81080 81072 (01)00884838068421(21)81072 81103 (01)00884838068421(21)81103 81113 (01)00884838068421(21)81113 81123 (01)00884838068421(21)81123 81128 (01)00884838068421(21)81128 81137 (01)00884838068421(21)81137 81178 (01)00884838068421(21)81178
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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.