Recall record at a glance
| Official record | Z-1694-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Philips North America, LLC |
| Report date | Jun 12, 2019 |
| Recall initiation date | Mar 28, 2019 |
| Location | Andover, MA, United States |
Official product description
IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 453564615331, 453564615351, and 453564615371 Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.
Why the product was recalled
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
Distribution information
Worldwide distribution - US Nationwide and to 71 countries.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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