Reported Jun 20, 2018 · Terminated
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351
Philips Electronics North America Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
IntelliVue MX40 Patient MonitorSoftware Versions B.05B.06B.06.5XModel 865351
- Lot codes and dates
- All devices since release of B.05 (March 2016) prefix date code >/= US096
- Amount recalled
- 7,178
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Five warning statements are missing from the instructions for use.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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