CLASS II ONGOING Device recall · Reported 14 Jan 2026 · FDA Enforcement Report
Philips Smart-hopping 2.0 AP 1.4 GHz recalled by Philips North America
Philips North America is recalling Philips Smart-hopping 2.0 AP 1.4 GHz, distributed nationwide in the US. The recall was initiated on 12 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1033-2026
- FDA event ID
- 98158
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Dec 2025
- FDA classified
- 8 Jan 2026
- Reported
- 14 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 12 Dec 2025 | Recall initiated by company | |
| 8 Jan 2026 | Classified by FDA | +27 days |
| 14 Jan 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model No. 867216; UDI [Serial No.]: , (01)00884838099876(21)DK32800791[DK32800791], (01)00884838099876(21)DK32800825[DK32800825], (01)00884838099876(21)DK32800918[DK32800918], (01)00884838099876(21)DK32800947[DK32800947], (01)00884838099876(21)DK32801055[DK32801055], (01)00884838099876(21)DK32801076[DK32801076], (01)00884838099876(21)DK32801098[DK32801098], (01)00884838099876(21)DK32801120[DK32801120], (01)00884838099876(21)DK32801188[DK32801188], (01)00884838099876(21)DK32801197[DK32801197], (01)00884838099876(21)DK32801225[DK32801225], (01)00884838099876(21)DK32801235[DK32801235], (01)00884838099876(21)DK32801252[DK32801252], (01)00884838099876(21)DK32801306[DK32801306], (01)00884838099876(21)DK32801338[DK32801338], (01)00884838099876(21)DK33402127[DK33402127], (01)00884838099876(21)DK33402141[DK33402141], (01)00884838099876(21)DK33402210[DK33402210], (01)00884838099876(21)DK33402281[DK33402281], (01)00884838099876(21)DK33402309[DK33402309], 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(01)00884838099876(21)DK51313342[DK51313342], (01)00884838099876(21)DK51313388[DK51313388], (01)00884838099876(21)DK51313389[DK51313389], (01)00884838099876(21)DK51313498[DK51313498], (01)00884838099876(21)DK51313526[DK51313526], (01)00884838099876(21)DK51313533[DK51313533], (01)00884838099876(21)DK51313613[DK51313613], (01)00884838099876(21)DK51313618[DK51313618], (01)00884838099876(21)DK51313621[DK51313621], (01)00884838099876(21)DK51313681[DK51313681], (01)00884838099876(21)DK51313712[DK51313712], (01)00884838099876(21)DK51313782[DK51313782], (01)00884838099876(21)DK51313853[DK51313853], (01)00884838099876(21)DK51813974[DK51813974], (01)00884838099876(21)DK51814002[DK51814002], (01)00884838099876(21)DK51814017[DK51814017], (01)00884838099876(21)DK51814145[DK51814145], (01)00884838099876(21)DK51814159[DK51814159], (01)00884838099876(21)DK51814193[DK51814193], (01)00884838099876(21)DK51814242[DK51814242], (01)00884838099876(21)DK51814253[DK51814253], (01)00884838099876(21)DK51814262[DK51814262], (01)00884838099876(21)DK51814274[DK51814274], (01)00884838099876(21)DK51814295[DK51814295], (01)00884838099876(21)DK51814325[DK51814325], (01)00884838099876(21)DK51814331[DK51814331], (01)00884838099876(21)DK51814345[DK51814345], (01)00884838099876(21)DK51814466[DK51814466], (01)00884838099876(21)DK52014528[DK52014528], (01)00884838099876(21)DK52014543[DK52014543], (01)00884838099876(21)DK52014557[DK52014557], (01)00884838099876(21)DK52014562[DK52014562], (01)00884838099876(21)DK52014623[DK52014623], (01)00884838099876(21)DK52014635[DK52014635], (01)00884838099876(21)DK52014682[DK52014682], (01)00884838099876(21)DK52014762[DK52014762], (01)00884838099876(21)DK52014763[DK52014763], (01)00884838099876(21)DK52014851[DK52014851], (01)00884838099876(21)DK52014854[DK52014854], (01)00884838099876(21)DK52014858[DK52014858], (01)00884838099876(21)DK52014873[DK52014873], (01)00884838099876(21)DK52014876[DK52014876], (01)00884838099876(21)DK52014877[DK52014877], (01)00884838099876(21)DK52014940[DK52014940], (01)00884838099876(21)DK52015039[DK52015039], (01)00884838099876(21)DK52015075[DK52015075], (01)00884838099876(21)DK52015080[DK52015080], (01)00884838099876(21)DK52115152[DK52115152], (01)00884838099876(21)DK52115179[DK52115179], (01)00884838099876(21)DK52115266[DK52115266], (01)00884838099876(21)DK52115272[DK52115272], (01)00884838099876(21)DK52115273[DK52115273], (01)00884838099876(21)DK52115278[DK52115278], (01)00884838099876(21)DK52115302[DK52115302], (01)00884838099876(21)DK52115371[DK52115371], (01)00884838099876(21)DK52115383[DK52115383], (01)00884838099876(21)DK52115584[DK52115584], (01)00884838099876(21)DK52115587[DK52115587], (01)00884838099876(21)DK52115679[DK52115679], (01)00884838099876(21)DK52315787[DK52315787], (01)00884838099876(21)DK52315839[DK52315839], (01)00884838099876(21)DK52315847[DK52315847], (01)00884838099876(21)DK52315891[DK52315891], (01)00884838099876(21)DK52315919[DK52315919], (01)00884838099876(21)DK52315940[DK52315940], (01)00884838099876(21)DK52315942[DK52315942], (01)00884838099876(21)DK52315948[DK52315948], (01)00884838099876(21)DK52315956[DK52315956], (01)00884838099876(21)DK52315965[DK52315965], (01)00884838099876(21)DK52315969[DK52315969], (01)00884838099876(21)DK52315979[DK52315979], (01)00884838099876(21)DK52315988[DK52315988], (01)00884838099876(21)DK52316026[DK52316026], (01)00884838099876(21)DK52316045[DK52316045], (01)00884838099876(21)DK52316053[DK52316053], (01)00884838099876(21)DK52316112[DK52316112], (01)00884838099876(21)DK52316134[DK52316134], (01)00884838099876(21)DK52316156[DK52316156], (01)00884838099876(21)DK52316235[DK52316235], (01)00884838099876(21)DK52316258[DK52316258], (01)00884838099876(21)DK52316272[DK52316272], (01)00884838099876(21)DK52316279[DK52316279], (01)00884838099876(21)DK52316283[DK52316283], (01)00884838099876(21)DK52316292[DK52316292], (01)00884838099876(21)DK52316312[DK52316312], (01)00884838099876(21)DK52316319[DK52316319], (01)00884838099876(21)DK52316322[DK52316322], (01)00884838099876(21)DK52316335[DK52316335], (01)00884838099876(21)DK52316395[DK52316395], (01)00884838099876(21)DK52516487[DK52516487], (01)00884838099876(21)DK52517004[DK52517004].
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Philips North America
All 558| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Upgrade to MR recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Ingenia Elition S and Ingenia Elition recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Ingenia Ambition S and Ingenia Ambition recalled | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Ingenia Blue Seal SE and Blue Seal XE recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
Other Patient Monitors recalls
All 1,022| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | Panorama and Telemetry Monitoring System recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |