Philips North America Llc: Philips MRI Systems Recalled Due to Loose Screws and Patient Entrapment Risk

Agency Publication Date: September 20, 2024

Summary

Philips North America Llc has recalled approximately 385 MRI diagnostic systems, including various Ingenia and MR models, because assembly screws within the Integrated Radio Frequency (IRF) Carrier may loosen and protrude. These loose screws can interfere with moving parts, potentially blocking the horizontal tabletop and trapping a patient inside the machine bore. This defect may lead to significant delays in diagnosis or cause patient anxiety if they are stuck inside the machine longer than expected.

Risk

Protruding screws can physically block the movement of the patient tabletop, preventing it from exiting the MRI bore. This creates a risk that a patient could be trapped inside the machine for an extended period, leading to distress or a delay in necessary medical treatment.

What You Should Do

Identify if your facility is using an affected MRI system by checking the model and serial numbers against the list of 385 units, including Evolution Upgrade 3.0T, Ingenia 1.5T, 3.0T, Ambition, Elition, and MR 5300/7700 models.
Check for specific serial numbers such as 85675 (Evolution), 45601 (Ingenia 1.5T), 85625 (Ingenia 3.0T), 27506 (Ambition S), or 63027 (MR 5300) located on the device identification plate.
If you identify an affected unit, contact Philips North America Llc or your healthcare provider's maintenance department immediately to schedule a technical inspection and repair of the IRF Carrier assembly.
Follow any specific instructions provided in the notification letter sent by Philips to ensure the safety of patients during imaging procedures.
Contact Philips North America Llc directly for technical support and to confirm if a field service engineer has been dispatched to your location.
For further information or to report concerns, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer field service inspection and correction.

How to: Contact your healthcare provider or Philips North America Llc for inspection and repair of the loose carrier assembly screws.

Affected Products

Product: Evolution Upgrade 3.0T

Model / REF:

782117

782143

Lot Numbers:

Serial Numbers: 85675, 85687, 85695

Product: Ingenia 1.5T

Model / REF:

782115

782101

782140

Lot Numbers:

Serial Numbers: 45601, 61291, 61312, 61315, 61328, 61336, 61337, 61339, 61348, 61349, 61351, 61354, 61355, 61356, 61357, 61359, 61360, 61361, 61362, 61363, 61364, 61367, 61371, 61373, 61374, 61375, 61376, 61377, 61378, 61380, 61383, 61384, 61394, 61395, 61397, 61403, 61404, 61406, 61407, 61412, 61415, 61416, 87645, 87648, 87649, 87651, 87654, 87655

Product: Ingenia 3.0T

Model / REF:

782103

Lot Numbers:

Serial Numbers: 85625, 85626, 85628, 85630, 85633, 85637, 85638, 85641, 85642, 85646, 85650, 85652, 85653, 85654, 85656, 85657, 85658, 85659, 85660, 85662, 85664, 85666, 85667, 85668, 85672, 85674, 85682, 85683, 85686, 85692, 85696, 85701, 85713

Product: Ingenia 3.0T CX

Model / REF:

782105

Lot Numbers:

Serial Numbers: 78547, 78557, 78559, 78560, 78562, 78564, 78565, 78566

Product: Ingenia Ambition S

Model / REF:

782108

781359

782133

Lot Numbers:

Serial Numbers: 27506, 27508, 27509, 27512, 27514, 27515, 27516, 27517, 27518, 27519, 27520, 27523, 27524, 27525, 27526, 27528, 27531, 48146, 48164, 48550, 48556, 48588, 48589, 48608, 48612, 48627, 48648, 48661, 48662, 48663, 48664, 48665, 48666, 48667, 48669, 48672, 48679, 48686, 48688, 48694, 48696, 48697, 48698, 48699, 48700, 48707, 48708, 48710, 48714, 48715, 48721, 48725, 48726, 48728, 48729, 48738, 48744, 48749, 48754, 48800, 48804, 48810, 48813, 48833

Product: Ingenia Ambition X

Model / REF:

782109

Lot Numbers:

Serial Numbers: 47558, 47602, 47606, 47608, 47609, 47614, 47615, 47617, 47621, 47622, 47625, 47626, 47628, 47630, 47634, 47644, 47646, 47651, 47654, 47656, 47657, 47660, 47665, 47666, 47667, 47668, 47671, 47672, 47674, 47677, 47678, 47679, 47680, 47681, 47684, 47685, 47687, 47688, 47694, 47695, 47697, 47698, 47700, 47701, 47702, 47703, 47705, 47706, 47708, 47709, 47710, 47716, 47733, 47737, 47738, 47753, 47755, 47759, 47785, 47791, 47800, 47802, 47804

Product: Ingenia Elition S

Model / REF:

782150

782106

Lot Numbers:

Serial Numbers: 26020, 26023, 26026, 26034, 46240, 46270, 46310, 46315, 46324, 46352

Product: Ingenia Elition X

Model / REF:

782151

782119

781358

782107

782136

Lot Numbers:

Serial Numbers: 26500, 26505, 28502, 28509, 45393, 45467, 45599, 62029, 62041, 62051, 62052, 62061, 62066, 62070, 62071, 62081, 62082, 62083, 62091, 62103, 62111, 62113, 62114, 62120, 62126, 62129, 62147, 62148, 62186, 62187, 62188, 66001, 66002

Product: MR 5300

Model / REF:

782110

Lot Numbers:

Serial Numbers: 63027, 63035, 63039, 63066, 63068, 63070, 63076, 63078, 63083, 63084, 63086, 63092, 63094, 63096, 63097, 63103, 63104, 63106, 63109, 63112, 63113, 63115, 63122, 63123, 63125, 63128, 63130, 63132, 63135, 63137, 63140, 63141, 63142, 63143, 63144, 63146, 63148, 63149, 63150, 63151, 63152, 63154, 63157, 63160, 63161, 63168, 63169, 63172, 63174, 63177, 63178, 63183, 63186, 63190, 63191, 63193, 63197, 63201, 63203, 63211, 63229, 63238, 63248, 63263, 63272, 63288, 63367, 63370

Product: MR 7700

Model / REF:

782120

Lot Numbers:

Serial Numbers: 65013, 65025, 65041, 65030, 65023, 65031, 65001

Product: SmartPath to dStream for 1.5T

Model / REF:

782112

781260

Lot Numbers:

Serial Numbers: 8876, 10190, 10521, 13021, 13023, 18520, 18892, 18942, 20159, 21127, 21158, 21513, 21726, 21803, 22027, 22048, 22093, 22247, 30054, 30273, 32250, 32355, 32412, 32419, 32469, 32539, 32724, 32827, 33371, 33639, 39070, 75067

Product: SmartPath to dStream for XR and 3.0T

Model / REF:

782113

781270

782129

Lot Numbers:

Serial Numbers: 17271, 17389, 17439, 17449, 17504, 24039, 24077, 34055, 34072, 34129, 34262, 38117, 38166, 38222

Product: SmartPath to Ingenia Elition X

Model / REF:

782118

Lot Numbers:

Serial Numbers: 85661, 85676

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95289

Status: Active

Manufacturer: Philips North America Llc

Sold By: Authorized Medical Device Distributors; Direct Hospital Sales

Manufactured In: United States

Units Affected: 13 products (3 units; 48 units; 33 units; 8 units; 64 units; 63 units; 10 units; 33 units; 68 units; 7 units; 32 units; 14 units; 2 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if your facility is using an affected MRI system by checking the model and serial numbers against the list of 385 units, including Evolution Upgrade 3.0T, Ingenia 1.5T, 3.0T, Ambition, Elition, and MR 5300/7700 models.

Check for specific serial numbers such as 85675 (Evolution), 45601 (Ingenia 1.5T), 85625 (Ingenia 3.0T), 27506 (Ambition S), or 63027 (MR 5300) located on the device identification plate.

If you identify an affected unit, contact Philips North America Llc or your healthcare provider's maintenance department immediately to schedule a technical inspection and repair of the IRF Carrier assembly.

Follow any specific instructions provided in the notification letter sent by Philips to ensure the safety of patients during imaging procedures.

Contact Philips North America Llc directly for technical support and to confirm if a field service engineer has been dispatched to your location.

For further information or to report concerns, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: Evolution Upgrade 3.0T

Model / REF:

782117

782143

Lot Numbers:

Serial Numbers: 85675, 85687, 85695

Product: Ingenia 1.5T

Model / REF:

782115

782101

782140

Lot Numbers:

Product: Ingenia 3.0T

Model / REF:

782103

Lot Numbers:

Product: Ingenia 3.0T CX

Model / REF:

782105

Lot Numbers:

Serial Numbers: 78547, 78557, 78559, 78560, 78562, 78564, 78565, 78566

Product: Ingenia Ambition S

Model / REF:

782108

781359

782133

Lot Numbers:

Product: Ingenia Ambition X

Model / REF:

782109

Lot Numbers:

Product: Ingenia Elition S

Model / REF:

782150

782106

Lot Numbers:

Serial Numbers: 26020, 26023, 26026, 26034, 46240, 46270, 46310, 46315, 46324, 46352

Product: Ingenia Elition X

Model / REF:

782151

782119

781358

782107

782136

Lot Numbers:

Product: MR 5300

Model / REF:

782110

Lot Numbers:

Product: MR 7700

Model / REF:

782120

Lot Numbers:

Serial Numbers: 65013, 65025, 65041, 65030, 65023, 65031, 65001

Product: SmartPath to dStream for 1.5T

Model / REF:

782112

781260

Lot Numbers:

Product: SmartPath to dStream for XR and 3.0T

Model / REF:

782113

781270

782129

Lot Numbers:

Serial Numbers: 17271, 17389, 17439, 17449, 17504, 24039, 24077, 34055, 34072, 34129, 34262, 38117, 38166, 38222

Product: SmartPath to Ingenia Elition X

Model / REF:

782118

Lot Numbers:

Serial Numbers: 85661, 85676

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95289

Status: Active

Manufacturer: Philips North America Llc

Sold By: Authorized Medical Device Distributors; Direct Hospital Sales

Manufactured In: United States

Units Affected: 13 products (3 units; 48 units; 33 units; 8 units; 64 units; 63 units; 10 units; 33 units; 68 units; 7 units; 32 units; 14 units; 2 units)

Distributed To: Nationwide