Ingenia recallZ-0715-2024 · Philips North America · initiated Jul 15, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips North America or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.)
FDA root cause category: Process change control
What the company is doing
Starting in July 2021, Philips Field Service Engineers (FSE) visited impacted customer sites to inspect the affected systems and turn on the circuit breaker of the extended battery of the UPS where required. All impacted systems were addressed as of February 9, 2023. Instructions for manufacturing and installation were updated on October 31, 2020, which included more detailed instructions for the correct setting of the circuit breaker.
Recall details
- Recall number
- Z-0715-2024
- Status
- Open, Classified
- Initiated by the company
- Jul 15, 2021
- Posted by the FDA
- Jan 11, 2024
- Recalling firm
- Philips North America
- Quantity
- 56 US; 169 ROW
- Product code
- LNI
- FDA submissions
- K213583
- Distribution
- 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.
Product description
(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
(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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Ingenia Ingenia Ambition XPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging12 recalls12 reports
- Ingenia Ingenia Ambition SPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging11 recalls2 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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