Philips MR Patient Care Portal 5000 Units Recalled for Intermittent Audio Failure
Philips has recalled MR Patient Care Portal 5000 desktop units (Model 453564792561) due to intermittent audio failure. The device may fail to produce audio, and standard troubleshooting does not reliably resolve the issue.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The intermittent audio failure is a functional defect that requires correction but does not present immediate patient harm.
Plain-English summary
Philips North America LLC is recalling MR Patient Care Portal 5000 desktop units (Model Number 453564792561), a component of medical device system 866162, due to intermittent audio failure. The device may fail to produce audio, and standard troubleshooting procedures including power cycling and AC power reconnection do not reliably resolve the issue.
A total of 115 units have been distributed domestically in the United States to the following states: Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Washington, and Wyoming. An additional 193 units have been distributed internationally to Australia, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Malta, Netherlands, Norway, Poland, Portugal, Qatar, Singapore, Slovakia, Spain, Sweden, Switzerland, and United Kingdom.
The recall affects units with specific serial numbers identified in the recall notice. Affected units in the United States are marked with code 01.02.00, while international units are marked with code 01.01.00. The device identifier (UDI-DI) is 00884838091948.
Consumers and healthcare facilities with affected units should contact Philips North America LLC immediately for repair or replacement instructions to restore audio functionality.
The recalled product
- Product
- MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
- Manufacturer
- Philips North America Llc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 01.02.00 - United States
- Puerto Rico
Distribution
Related recalls
Same manufacturer · Philips North America Llc
See all →- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- ModeratePhilips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips MR 7700 MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
- ModeratePhilips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
Same hazard · audio failure
See all →- HighCentral monitoring workstations recalled over audio failure and screen freezing
FDA (Devices) · 2025-12-24
- ModerateInvivo Expression Information Portal Recalled for Audio Failure
FDA (Devices) · 2014-02-26
Similar recalls
- HighPhilips MR 5300 MRI System Patient Support Table Floor Plate May Be Incorrectly Installed
FDA (Devices) · 2024-04-24
- HighPhilips IntelliVue MP2 Patient Monitors Recalled for Speaker Failure
FDA (Devices) · 2020-12-16
- ModerateInvivo Expression Information Portal Recalled for Audio Failure
FDA (Devices) · 2014-02-26
- HighPhilips Intera 1.5T MRI System Patient Support Table Floor Plate Installation Defect
FDA (Devices) · 2024-04-24
- HighPhilips MRI Patient Support Table Floor Plate May Be Incorrectly Installed
FDA (Devices) · 2024-04-24
- HighPhilips IntelliVue MX4O Monitor Recall for Alarm Failure
FDA (Devices) · 2017-04-12