Philips recalls IntelliVue MX40 patient monitors with software versions B.05-B.06.5X (released March 2:2016) due to missing warning statements in instructions. Affected units have model 865350 and date codes >= US096.
Five warning statements are missing from the instructions for use.
Philips is recalling IntelliVue MX40 patient monitors with specific software versions because the instructions for use lack five critical warning statements. This could lead to improper use if healthcare providers don't follow the full safety guidelines.
The missing warning statements in the instructions could lead to improper use of the monitor. Without these warnings, healthcare providers might not follow all safety procedures, potentially causing errors in patient monitoring.
Healthcare providers using IntelliVue MX40 patient monitors with software versions B.05 through B.06.5X are most at risk. Patients are not directly affected by this recall.
Check if your monitor has software versions B.05, B.06, or B.06.5X. The model number is 865350, and the date code starts with US096 (released March 2016 or later).
Review your monitor's software version in the device settings to confirm it is B.05, B.06, or B.06.5X.
Ensure your monitor's model number is 865350 and the date code starts with US096 (released March 2016 or later).
No, the recall does not require immediate discontinuation. The missing warnings are a documentation issue, not an active hazard.
Check the software version (B.05, B.06, or B.06.5X) and model number (865350) with a date code starting with US096 (released March 2016 or later).
The recall does not provide a fix. The issue is a missing warning statement in the instructions, which requires updated documentation.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2141-2018 — Philips Philips Hello, I own a Philips that is covered by recall Z-2141-2018 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.
