CLASS II ONGOING Device recall · Reported 16 Jun 2021 · FDA Enforcement Report
Ingenia Ambition S recalled by Philips North America
Philips North America is recalling Ingenia Ambition S, distributed in 11 states. The recall was initiated on 23 Apr 2021 and the FDA has classified it as Class II.
Check your package
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-1796-2021
- FDA event ID
- 87962
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Apr 2021
- FDA classified
- 4 Jun 2021
- Reported
- 16 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 23 Apr 2021 | Recall initiated by company | |
| 4 Jun 2021 | Classified by FDA | +42 days |
| 16 Jun 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet.
Product as listed by the FDA
Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.
Where it was distributed
Domestic: FL, GA, MI, MO, NH, NJ, NY, PA, SC, TX, VT. Foreign: Australia, Austria, Bangladesh, Belgium, Brazil, Denmark, Finland, France, Germany, Iraq, Italy, Japan, Libya, Moldova, Netherlands, Oman, Spain, Switzerland, Thailand, United Arab Emirates, United Kingdom.
FloridaGeorgiaMichiganMissouriNew HampshireNew JerseyNew YorkPennsylvaniaSouth CarolinaTexasVermont
Questions about this recall
Why was it recalled?
The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet.
Which lots are affected?
REF 781359/ UDI-DI 00884838090057 Serial numbers: 48000 48001 48003 48004 48009 48005 48015 48017 48020 48011 48022 48012 48014 48028 48026 48037 48023 48043 48019 48160 48144 48180 48112 48052 ***Updated November 2023*** Added Serial Numbers 48051 48010 48038 48018 48039 48027 48122 48046 48036 48047 48133 48056 48169 48148 48154 48055 48128 48194 48173 48134 48040 48155 48186 48035 48181 48188 48198
Where was it sold?
Domestic: FL, GA, MI, MO, NH, NJ, NY, PA, SC, TX, VT. Foreign: Australia, Austria, Bangladesh, Belgium, Brazil, Denmark, Finland, France, Germany, Iraq, Italy, Japan, Libya, Moldova, Netherlands, Oman, Spain, Switzerland, Thailand, United Arab Emirates, United Kingdom.
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.
Other products in this recall event
1 other product · FDA event 87962This product is part of a recall event; the main page for the event is Ingenia Ambition X recalled by Philips North America.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ingenia Ambition X recalled by Philips North America | Philips North America | Other | 11 states |
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