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(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)

FDA Device Recall #Z-0715-2024 — Class II — July 15, 2021

Recall Summary

Recall Number Z-0715-2024
Classification Class II — Moderate risk
Date Initiated July 15, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips North America
Location Cambridge, MA
Product Type Devices
Quantity 56 US; 169 ROW

Product Description

(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)

Reason for Recall

The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.)

Distribution Pattern

Domestic distribution to the following states and territories: CA DE FL GA IL KY MA ME MI MO NH NJ NM NY OH PA SC TN TX VA VT WI WY, and PR. International distribution worldwide.

Lot / Code Information

(1) Ingenia Ambition X UDI-DI 00884838090040 Serial Numbers 47000 47001 47002 47003 47004 47006 47007 47009 47011 47012 47013 47014 47015 47016 47017 47018 47019 47020 47022 47023 47024 47025 47026 47027 47028 47029 47030 47032 47033 47034 47035 47037 47038 47039 47040 47041 47043 47044 47045 47047 47048 47049 47050 47051 47052 47053 47054 47056 47057 47058 47059 47060 47061 47062 47063 47064 47065 47066 47067 47068 47070 47071 47072 47074 47075 47077 47078 47080 47081 47082 47083 47084 47085 47088 47089 47091 47092 47093 47094 47095 47096 47097 47098 47099 47174 47175 47177 47183 47184 47187 47188 47190 47192 47193 47194 47195 47196 47197 47198 47199 47202 47203 47206 47208 47209 47211 47215 47216 47219 47220 47221 47225 47226 47227 47244 47245 47247 47248 47252 47255 47258 47260 47262 47268 47269 47270 47271 47272 47275 47276 47279 47284 47297 47298 47282 (2) Ingenia Ambition S UDI-DI 00884838090057 Serial Numbers 48000 48001 48003 48004 48005 48009 48010 48011 48012 48013 48014 48015 48016 48017 48018 48019 48020 48022 48023 48026 48027 48028 48031 48032 48033 48034 48035 48036 48037 48038 48039 48040 48043 48044 48045 48046 48047 48049 48050 48051 48052 48053 48055 48056 48112 48120 48122 48127 48128 48129 48130 48131 48133 48134 48136 48144 48148 48151 48152 48153 48154 48155 48158 48160 48162 48166 48167 48169 48171 48172 48173 48174 48179 48180 48181 48182 48183 48184 48186 48187 48188 48190 48191 48192 48194 48196 48198 48199 48200 48207

Other Recalls from Philips North America

Recall # Classification Product Date
Z-1156-2026 Class II Patient Information Center iX; Software Versio... Dec 22, 2025
Z-1204-2026 Class II Evolution Upgrade 1.5T. Product Codes (REF): ... Dec 3, 2025
Z-1215-2026 Class II SmartPath to dStream for 3.0T. Product Code (... Dec 3, 2025
Z-1207-2026 Class II Ingenia 3.0T. Product Code (REF): (1) 781342,... Dec 3, 2025
Z-1209-2026 Class II Ingenia Ambition S. Product Code (REF): 78210... Dec 3, 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.

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