(1) Ingenia Ambition X (Product Number 781356)
Medical device recall Z-0715-2024. Published in FDA’s Enforcement Report on Jan 17, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 17, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 24 states named in where it went
- 56 US; 169 ROW how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
56 US; 169 ROW, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
(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…
Every code shown here, 1,469 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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
24 states and territories.
Every one of them
- California
- Delaware
- Florida
- Georgia
- Illinois
- Kentucky
- Massachusetts
- Maine
- Michigan
- Missouri
- New Hampshire
- New Jersey
- New Mexico
- New York
- Ohio
- Pennsylvania
- Puerto Rico
- South Carolina
- Tennessee
- Texas
- Virginia
- Vermont
- Wisconsin
- Wyoming
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 15, 2021.
- FDA classified it on Jan 11, 2024.
- FDA’s Enforcement Report published it on Jan 17, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips North America, of Cambridge, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.