CLASS II Device recall · Reported 1 Sep 2021 · FDA Enforcement Report
Ingenia 0T-Magnetic Resonance Medical Electrical Systems recalled
Philips North America is recalling Ingenia 0T-Magnetic Resonance Medical Electrical Systems indicated for use as a, distributed nationwide in the US. The recall was initiated on 30 Jul 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-2343-2021
- FDA event ID
- 88461
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jul 2021
- FDA classified
- 25 Aug 2021
- Reported
- 1 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 30 Jul 2021 | Recall initiated by company | |
| 25 Aug 2021 | Classified by FDA | +26 days |
| 1 Sep 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
Product as listed by the FDA
Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781342
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, MD, MD, NH, NY, OH, TN, TX, VA and the countries of Canada, Mexico, Australia, Austria, Chile, China, Czech Republic, Denmark, France, Germany, India, Indonesia, Italy, Japan, Korea, Republic of Lebanon, Netherlands, Romania, Russian Federation, Saudi Arabia, Spain, Turkey, Ukraine, United Kingdom.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoMarylandNew HampshireNew YorkOhioTennesseeTexasVirginia
Questions about this recall
Is Ingenia 0T-Magnetic Resonance Medical Electrical Systems indicated for use as a recalled?
Yes. Philips North America recalled Ingenia 0T-Magnetic Resonance Medical Electrical Systems indicated for use as a on 30 Jul 2021. The recall is Class II and its status is Terminated. Recall number Z-2343-2021.
Why was it recalled?
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
Which lots are affected?
S/N and UDI: 85275 (01)00884838055339(21)85275; 85278 (01)00884838055339(21)85278; 85394 (01)00884838055339(21)85394. OUS: 85393 (01)00884838055339 85332 (01)00884838055339 85334 (01)00884838055339 85336 (01)00884838055339 85349 (01)00884838055339 85350 (01)00884838055339 85355 (01)00884838055339 85370 (01)00884838055339 85371 (01)00884838055339 85382 (01)00884838055339 85384 (01)00884838055339 85385 (01)00884838055339 85398 (01)00884838055339 85348 (01)00884838055339 85149 (01)00884838055339 85367 (01)00884838055339 85388 (01)00884838055339
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, MD, MD, NH, NY, OH, TN, TX, VA and the countries of Canada, Mexico, Australia, Austria, Chile, China, Czech Republic, Denmark, France, Germany, India, Indonesia, Italy, Japan, Korea, Republic of Lebanon, Netherlands, Romania, Russian Federation, Saudi Arabia, Spain, Turkey, Ukraine, 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 21 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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