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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88461

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 30, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips North America Llc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 7

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

Z-2341-2021
Recall number
Z-2341-2021
Initiated
July 30, 2021
Classification
Class II
Status
Terminated
Recalling firm
Philips North America Llc
Quantity
2 units US; 16 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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

Code information

S/N and UDI: US: 61044 (01)00884838099715(21)61044; 61047 (01)00884838099715(21)61047. OUS: 61028 (01)00884838099715 61008 (01)00884838099715 61025 (01)00884838099715 61026 (01)00884838099715 61034 (01)00884838099715 61035 (01)00884838099715 61042 (01)00884838099715 61046 (01)00884838099715 61040 (01)00884838099715 61041 (01)00884838099715 61018 (01)00884838099715 61017 (01)00884838099715 61032 (01)00884838099715 61043 (01)00884838099715 61033 (01)00884838099715 61064 (01)00884838099715

Distribution pattern

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.

device · product 2 of 7

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

Z-2342-2021
Recall number
Z-2342-2021
Initiated
July 30, 2021
Classification
Class II
Status
Terminated
Recalling firm
Philips North America Llc
Quantity
3 units US; 24 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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

Code information

S/N and UDI: 84344 (01)00884838055322(21)84344; 87019 (01)00884838055322(21)87019; 87231 (01)00884838055322(21)87231. OUS: 87171 (01)00884838055322 84943 (01)00884838055322 87142 (01)00884838055322 87249 (01)00884838055322 87252 (01)00884838055322 87195 (01)00884838055322 87129 (01)00884838055322 87136 (01)00884838055322 87175 (01)00884838055322 87196 (01)00884838055322 87197 (01)00884838055322 87235 (01)00884838055322 87187 (01)00884838055322 87212 (01)00884838055322 84572 (01)00884838055322 87116 (01)00884838055322 87152 (01)00884838055322 87161 (01)00884838055322 87237 (01)00884838055322 87244 (01)00884838055322 87090 (01)00884838055322 87093 (01)00884838055322 87259 (01)00884838055322 87209 (01)00884838055322

Distribution pattern

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.

device · product 3 of 7

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

Z-2343-2021
Recall number
Z-2343-2021
Initiated
July 30, 2021
Classification
Class II
Status
Terminated
Recalling firm
Philips North America Llc
Quantity
3 units US; 17 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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

Code information

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

Distribution pattern

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.

device · product 4 of 7

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

Z-2344-2021
Recall number
Z-2344-2021
Initiated
July 30, 2021
Classification
Class II
Status
Terminated
Recalling firm
Philips North America Llc
Quantity
6 units; 12 OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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

Code information

S/N and UDI: US: 45245 (01)00884838088115(21)45245; 45247 (01)00884838088115(21)45247; 45261 (01)00884838088115(21)45261; 45263 (01)00884838088115(21)45263; 45264 (01)00884838088115(21)45264; 45269 (01)00884838088115(21)45269; OUS: 45215 (01)00884838088115; 45284 (01)00884838088115; 45253 (01)00884838088115; 45313 (01)00884838088115; 45265 (01)00884838088115; 45297 (01)00884838088115; 45218 (01)00884838088115; 45272 (01)00884838088115; 45281 (01)00884838088115; 45231 (01)00884838088115; 45278 (01)00884838088115; 45279 (01)00884838088115; 45245 (01)00884838088115; 45247 (01)00884838088115;

Distribution pattern

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.

device · product 5 of 7

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)

Z-2345-2021
Recall number
Z-2345-2021
Initiated
July 30, 2021
Classification
Class II
Status
Terminated
Recalling firm
Philips North America Llc
Quantity
11 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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

Code information

S/N and UDI: 78189 (01)00884838068452; 78272 (01)00884838068452; 78294 (01)00884838068452; 78295 (01)00884838068452; 78332 (01)00884838068452; 78335 (01)00884838068452; 78340 (01)00884838068452; 78345 (01)00884838068452; 78249 (01)00884838068452; 78324 (01)00884838068452; 78326 (01)00884838068452

Distribution pattern

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.

device · product 6 of 7

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)

Z-2346-2021
Recall number
Z-2346-2021
Initiated
July 30, 2021
Classification
Class II
Status
Terminated
Recalling firm
Philips North America Llc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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

Code information

S/N and UDI: N/A

Distribution pattern

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.

device · product 7 of 7

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)

Z-2347-2021
Recall number
Z-2347-2021
Initiated
July 30, 2021
Classification
Class II
Status
Terminated
Recalling firm
Philips North America Llc
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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

Code information

S/N and UDI: 46083 (01)00884838088108; 46084 (01)00884838088108; 46086 (01)00884838088108; 46054 (01)00884838088108; 46058 (01)00884838088108; 46082 (01)00884838088108; 46061 (01)00884838088108;

Distribution pattern

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.