Severity
Moderate
Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - Product Usage: The Expression Model MR400 MRI Patient Monitoring Systems is intended for use by healthcare professionals to monitor vital signs of patients undergoing MRI procedures and to provide signals for the synchronization of the MRI scanner.
Reported: April 8, 2020 Initiated: February 20, 2020 #Z-1616-2020 2214 units units
Philips North America, LLC issued this FDA Devices recall on April 8, 2020. Classified as Moderate severity (Class II). Approximately 2214 units units are affected. The recall was issued because: Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into the devic…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-1616-2020) was formally reported on April 8, 2020, with the manufacturer initiating the action on February 20, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips North America, LLC is listed as the recalling firm, operating out of Andover, MA. Federal records indicate 2214 units units are affected.
The documented reason for this recall is: Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into the device s Instructions for Use. As a result, the instructions for performing the O2 sensor calibration are… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution and countries of Utd Arab Emir, Albania, Austria, Australia, Azerbaijan, Bulgaria, Brazil, White Russia, Canada, Switzerland, Chile, Colombia, Czech Republic, German…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
2214 units
Related Recalls
6
6 from same agency
Product Description
Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - Product Usage: The Expression Model MR400 MRI Patient Monitoring Systems is intended for use by healthcare professionals to monitor vital signs of patients undergoing MRI procedures and to provide signals for the synchronization of the MRI scanner.
Reason for Recall
Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into the device s Instructions for Use. As a result, the instructions for performing the O2 sensor calibration are incorrect for customers performing this task with an MR400 device with software revisions: 01 .03.00, 01.04.00, 01 .05.00 and 01 .07.00
Details
- Recalling Firm
- Philips North America, LLC
- Units Affected
- 2214 units
- Distribution
- Worldwide distribution - US Nationwide distribution and countries of Utd Arab Emir, Albania, Austria, Australia, Azerbaijan, Bulgaria, Brazil, White Russia, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Hungary, Ireland, Israel, India, Iceland, Italy, Jamaica, Japan, Kyrgyzstan, Malaysia, Netherlands, Norway, Oman, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Uzbekistan, Viet Nam.
- Location
- Andover, MA
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1616-2020 |
| Date reported | April 8, 2020 |
| Date initiated | February 20, 2020 |
| Recalling firm | Philips North America, LLC |
| Units affected | 2214 units |
| Distribution | Worldwide distribution - US Nationwide distribution and countries of Utd Arab Emir, Albania, Austria, Australia, Azerbaijan, Bulgaria, Brazil, White Russia, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Denmark, Spain, F… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - Product Usage: The Expression Model MR400 MRI Patient Monitoring Systems is intended for use by healthcare professionals to monitor vital signs of patients undergoing MRI procedures and to provide signals for the synchronization of the MRI scanner.. Recalled by Philips North America, LLC. Units affected: 2214 units.
Why was this product recalled? ▼
Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into the device s Instructions for Use. As a result, the instructions for performing the O2 sensor calibration are incorrect for customers performing this task with an MR400 device with software revisions: 01 .03.00, 01.04.00, 01 .05.00 and 01 .07.00
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 8, 2020. Severity: Moderate. Recall number: Z-1616-2020.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distribution and countries of Utd Arab Emir, Albania, Austria, Australia, Azerbaijan, Bulgaria, Brazil, White Russia, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Hungary, Ireland, Israel, India, Iceland, Italy, Jamaica, Japan, Kyrgyzstan, Malaysia, Netherlands, Norway, Oman, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Uzbekistan, Viet Nam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1616-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).