CLASS II Device recall · Reported 1 Sep 2021 · FDA Enforcement Report
Achieva 3.0T-Magnetic Resonance Medical Electrical Systems recalled
Philips North America is recalling Achieva 3.0T-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-2346-2021
- 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
Achieva 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: 781277 (OUS)
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
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: N/A
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 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
6 other products · FDA event 88461This product is part of a recall event; the main page for the event is Ingenia Elition X-Magnetic Resonance Medical Electrical recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ingenia Elition X-Magnetic Resonance Medical Electrical recalled | Philips North America | Other | Nationwide | |
| CLASS II | Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems recalled | Philips North America | Other | Nationwide | |
| CLASS II | Ingenia 1.5T Evoluton- Magnetic Resonance Medical recalled | Philips North America | Other | Nationwide | |
| CLASS II | Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems recalled | Philips North America | Other | Nationwide | |
| CLASS II | Ingenia CX 3.0T-Magnetic Resonance Medical Electrical recalled | Philips North America | Other | Nationwide | |
| CLASS II | Ingenia Elition S-Magnetic Resonance Medical Electrical recalled | Philips North America | Other | Nationwide |
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