CLASS II ONGOING Device recall · Reported 17 Jan 2024 · FDA Enforcement Report

Ingenia Ambition X (Product Number 781356) recalled

Philips North America is recalling Ingenia Ambition X (Product Number 781356), distributed in 21 states. The recall was initiated on 15 Jul 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes(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

Quantity recalled56 US; 169 ROW

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0715-2024
FDA event ID: 93739
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 15 Jul 2021
FDA classified: 11 Jan 2024
Reported: 17 Jan 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

15 Jul 2021	Recall initiated by company
11 Jan 2024	Classified by FDA	+910 days
17 Jan 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.)

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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.

California Florida Georgia Illinois Kentucky Massachusetts Michigan Missouri New Hampshire New Jersey New Mexico New York Pennsylvania Puerto Rico South Carolina Tennessee Texas Virginia Vermont Wisconsin

Questions about this recall

Why was it 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.)

Which lots are affected?

(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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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