Device recall: Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The…

Class II FDA enforcement event 88461. Recall start date: 30 Jul 2021. Status in the FDA record: Terminated. Termination date: 25 Jul 2023.

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

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

Philips North America Llc started this device recall on 30 Jul 2021. The firm address in the FDA record is in Cambridge, MA. FDA put the recall in Class II. FDA event 88461 has 7 product records. The first FDA enforcement report date is 1 Sep 2021. The record gives the status Terminated, with the termination date 25 Jul 2023.

FDA enforcement report The 7 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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…

Recalling firm

Philips North America Llc, Cambridge, MA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

7 product records in the event.

FDA event 88461: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2341-2021	Ingenia 1.5T Evoluton- 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: 781315	2 units US; 16 units OUS	Class II	Terminated	1 Sep 2021
Z-2342-2021	Ingenia 1.5T-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: 781341	3 units US; 24 units OUS	Class II	Terminated	1 Sep 2021
Z-2343-2021	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	3 units US; 17 units OUS	Class II	Terminated	1 Sep 2021
Z-2344-2021	Ingenia Elition X-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: 781358	6 units; 12 OUS	Class II	Terminated	1 Sep 2021
Z-2345-2021	Ingenia CX 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: 78127 (OUS)	11 units	Class II	Terminated	1 Sep 2021
Z-2346-2021	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)	1 unit	Class II	Terminated	1 Sep 2021
Z-2347-2021	Ingenia Elition S-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: 781357 (OUS)	7 units	Class II	Terminated	1 Sep 2021

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2021: 900
Share of these events in Class II: 89%
Product records in this event: 7Median of the firm: 1
Events of the firm on the register: 129

Other events of the firm

Other FDA enforcement events of Philips North America Llc
Initiated	Product (first record)	Type	Class	Records
7 Aug 2026	Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes:	Device	Class II	4
1 Jul 2026	Cardiac Workstation 5000. Product Number: 860439.	Device	Class II	2
5 Jun 2026	Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5	Device	Class II	1
26 May 2026	Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A	Device	Class II	2
1 May 2026	DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.	Device	Class II	1
7 Jan 2026	Brilliance iCT; Product Code (REF): 728306;	Device	Class II	4
12 Dec 2025	Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.	Device	Class II	1
31 Oct 2025	IntelliVue MP2. Product Number: M8102A.	Device	Class II	22
29 Oct 2025	Incisive CT; Software Version Number: 4.5, 5.0, 5.1;	Device	Class II	2
13 Aug 2025	Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Chan	Device	Class II	10

Philips North America Llc: all 129 events

Official channels

FDA enforcement report Z-2341-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 88461. https://recallregister.com/fda/ii/88461/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: 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…
What quantity of product is in FDA event 88461?: The event has 7 product records. The first record gives this quantity: 2 units US; 16 units OUS
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2021 have the same class?: 89% of the 900 device events that started in 2021 are in Class II.