FDA recall, , Moderate risk
Philips Smart-Hopping 2.0 AP 1.4 GHz Patient Monitor
It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.
Summary by Recall Canary from the FDA notice
What happened
Philips North America Llc of Cambridge, Massachusetts recalled the Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. The recall began on December 12, 2025, and was added to the FDA's Enforcement Report on January 8, 2026. The product was distributed nationwide in the US.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
- UDI-DI
- 00884838099876
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Philips North America LlcCambridge, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98158
- Recall number
- Z-1033-2026
- Quantity recalled
- 13,470 Units
All recalls from Philips North America Llc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
