CLASS II Device recall · Reported 8 May 2019 · FDA Enforcement Report
Ingenia Ambition S (781359), Ingenia Ambition X recalled
Philips Medical Systems Nederlands is recalling Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device, distributed in Florida. The recall was initiated on 25 Mar 2019 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-1240-2019
- FDA event ID
- 82610
- Recalling firm
- Philips Medical Systems Nederlands, Best, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Mar 2019
- FDA classified
- 26 Apr 2019
- Reported
- 8 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 25 Mar 2019 | Recall initiated by company | |
| 26 Apr 2019 | Classified by FDA | +32 days |
| 8 May 2019 | 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
Magnet Energization Device (MED) can have a residual voltage on output terminal, may cause electrical shocks to personnel servicing the MED, MDD or connected cabling.
Product as listed by the FDA
Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the magnet. MED is abbreviation for Magnet Energize Device
Where it was distributed
US Distribution to state of: FL and Internationally to: Switzerland and Germany.
Questions about this recall
Why was it recalled?
Magnet Energization Device (MED) can have a residual voltage on output terminal, may cause electrical shocks to personnel servicing the MED, MDD or connected cabling.
Which lots are affected?
US Serial Number: 47004 OUS Serial Numbers: 47001, 47002, 48000
Where was it sold?
US Distribution to state of: FL and Internationally to: Switzerland and Germany.
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.
More recalls from Philips Medical Systems Nederlands
All 79| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Allura Xper System: Interventional Fluoroscopic recalled | Philips Medical Systems Nederlands | Device Malfunction | 10 states |
| Device | CLASS II | Azurion lnterventional Fluoroscopic X-ray System recalled | Philips Medical Systems Nederlands | Device Malfunction | Nationwide |
| Device | CLASS II | Foot Switches used with the following systems recalled | Philips Medical Systems Nederlands | Other | Nationwide |
| Device | CLASS II | Foot Switches used with Philips MultiDiagnost Eleva recalled | Philips Medical Systems Nederlands | Other | Nationwide |
| Device | CLASS II | Intera 1.5T High Performance recalled by Philips Medical Systems | Philips Medical Systems Nederlands | Other | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |