Philips recalls IntelliVue MX40 Patient Monitors with specific software versions due to missing warning statements in instructions. Affected units were sold since March 2016. No immediate action required but check for missing warnings.
Five warning statements are missing from the instructions for use.
Philips is recalling IntelliVue MX40 Patient Monitors with software versions B.05 through B.06.5X. The recall is because five warning statements are missing from the user instructions, which could lead to improper use if not addressed.
The missing warning statements could lead to improper use of the monitor if healthcare workers don't follow the correct procedures. This might result in incorrect patient monitoring or other safety issues.
Healthcare professionals using the IntelliVue MX40 Patient Monitor with the specified software versions are most at risk. Patients and staff using these monitors may be affected if the missing warnings cause improper use.
Check for the model number 865352 and software versions B.05, B.06, or B.06.5X. Devices were sold starting from March 2016 with a date code prefix of US096 or later.
Review the user instructions for the missing warning statements to confirm if your device is affected.
No immediate action is required. The recall is for missing warning statements, not a safety hazard that requires stopping use.
Software versions B.05, B.06, and B.06.5X are affected.
Check for the model number 865352 and software versions B.05, B.06, or B.06.5X. Devices were sold starting from March 2016 with a date code prefix of US096 or later.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2143-2018 — Philips Philips Hello, I own a Philips that is covered by recall Z-2143-2018 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.
