Philips recalls MR400 MRI Patient Monitoring Systems with specific software versions due to incorrect oxygen sensor calibration instructions. Affected units may have unsafe calibration procedures.
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
Philips is recalling MRI patient monitoring systems with software versions 01.03.00, 01.04.00, 01.05.00, and 01.07.00. The recall is because the instructions for calibrating the oxygen sensor are incorrect, which could lead to improper oxygen monitoring during MRI procedures.
The software versions have incorrect instructions for calibrating the oxygen sensor. This could result in improper oxygen monitoring during MRI procedures, potentially affecting patient safety.
Healthcare professionals using Philips MR400 MRI Patient Monitoring Systems with the specified software versions are most at risk. Patients undergoing MRI procedures may be affected if the oxygen sensor calibration is performed incorrectly.
Check if your Philips MR400 MRI Patient Monitoring System has model number 866185 and software versions 01.03.00, 01.04.00, 01.05.00, or 01.07.00.
Verify your device's software version by checking the model number and software version on the device label.
The instructions for performing oxygen sensor calibration are incorrect for the specified software versions, which could lead to improper oxygen monitoring during MRI procedures.
The recall does not specify a remedy, so contact Philips directly for guidance on how to proceed.
The hazard is low risk as the issue involves incorrect instructions rather than a physical defect that could cause immediate harm.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1616-2020 — Philips Philips Hello, I own a Philips that is covered by recall Z-1616-2020 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
