Philips recalls IntelliVue MX40 Patient Monitors with specific software versions due to missing warning statements in instructions. Affected units may not follow safety guidelines properly.
Five warning statements are missing from the instructions for use.
Philips is recalling IntelliVue MX4:0 Patient Monitors with software versions B.05, B.06, and B.06.5X (model 867146) because the instructions for use lack five critical warning statements. This could lead to improper use of the monitor, potentially causing safety risks.
The missing warning statements in the instructions could mean users don't know how to safely operate the monitor. This might lead to incorrect settings or missed safety alerts, which could be problematic in medical settings.
Healthcare professionals using the IntelliVue MX40 Patient Monitor with the specified software versions are most at risk. Patients and caregivers may also be affected if the monitor is not used correctly.
Check for the IntelliVue MX40 Patient Monitor with software versions B.05, B.06, or B.06.5X (model 867146). The recall applies to all devices with these specific software versions.
Review the software version on your IntelliVue MX40 Patient Monitor to confirm if it is B.05, B.06, or B.06.5X (model 867146).
This recall affects IntelliVue MX40 Patient Monitors with specific software versions (B.05, B.06, B.06.5X) and model 867146. Check your device's software version to see if you are affected.
The official recall notice does not specify a remedy for this issue. You should check the software version and contact Philips for further guidance if needed.
The missing warning statements in the instructions could lead to improper use, but the recall indicates a low-risk situation as no specific injury mechanism is described.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2144-2018 — Philips Philips Hello, I own a Philips that is covered by recall Z-2144-2018 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.