CLASS II ONGOING Device recall · Reported 25 Dec 2024 · 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 20 Nov 2024 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-0686-2025
- FDA event ID
- 95847
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Nov 2024
- FDA classified
- 17 Dec 2024
- Reported
- 25 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 20 Nov 2024 | Recall initiated by company | |
| 17 Dec 2024 | Classified by FDA | +27 days |
| 25 Dec 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The following four issues are included: 1. Certain Channel Settings may result in an Access Point preventing a connected client device from roaming to another Access Point potentially causing the client device to appear to drop out from the network. 2. if the Access Point experiences a disconnection from the Access Point Controller exceeding 4 minutes, the Access Point may not transition through the desired state to all for clean reconnection of the client radio link. 3. Potential to experience higher than expected data dropouts, device disassociations/reassociations for their wireless clients, and frequent "Loss of AP" alerts. 4. Potential for the Smart-hopping Access Point is affected by a software issue where the Access Point will resent after 82.85 days when the frame counter reaches its limit. This causes the latest synchronization check to fail and potential for loss of patient data.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
Where it was distributed
Nationwide distribution
Questions about this recall
Why was it recalled?
The following four issues are included: 1. Certain Channel Settings may result in an Access Point preventing a connected client device from roaming to another Access Point potentially causing the client device to appear to drop out from the network. 2. if the Access Point experiences a disconnection from the Access Point Controller exceeding 4 minutes, the Access Point may not transition through the desired state to all for clean reconnection of the client radio link. 3. Potential to experience higher than expected data dropouts, device disassociations/reassociations for their wireless clients, and frequent "Loss of AP" alerts. 4. Potential for the Smart-hopping Access Point is affected by a software issue where the Access Point will resent after 82.85 days when the frame counter reaches its limit. This causes the latest synchronization check to fail and potential for loss of patient data.
Which lots are affected?
GTIN: 00884838099876. Model Number: 867216. All software versions are affected. UDI Numbers: (01)00884838099876(21)DK34706344, (01)00884838099876(21)DK33603995, (01)00884838099876(21)DK34706512, (01)00884838099876(21)DK33402245, (01)00884838099876(21)DK34706012, (01)00884838099876(21)DK33402324, (01)00884838099876(21)DK33603538, (01)00884838099876(21)DK34405346, (01)00884838099876(21)DK32801033, (01)00884838099876(21)DK34705955, (01)00884838099876(21)DK40307155, (01)00884838099876(21)DK34405363, (01)00884838099876(21)DK33604046, (01)00884838099876(21)DK34706011, (01)00884838099876(21)DK34706010, (01)00884838099876(21)DK33402486, (01)00884838099876(21)DK34405820, (01)00884838099876(21)DK34405539, (01)00884838099876(21)DK34405788, (01)00884838099876(21)DK33403107, (01)00884838099876(21)DK33603456, (01)00884838099876(21)DK34706099, (01)00884838099876(21)DK32801250, (01)00884838099876(21)DK32801095, (01)00884838099876(21)DK33604249, (01)00884838099876(21)DK33403062, (01)00884838099876(21)DK34706432, (01)00884838099876(21)DK33403214, (01)00884838099876(21)DK33402554, (01)00884838099876(21)DK40307129, (01)00884838099876(21)DK33603678, (01)00884838099876(21)DK32801039, (01)00884838099876(21)DK33402660, (01)00884838099876(21)DK34706048, (01)00884838099876(21)DK33904683, (01)00884838099876(21)DK33402439, (01)00884838099876(21)DK34405702, (01)00884838099876(21)DK40306709, (01)00884838099876(21)DK32800996, (01)00884838099876(21)DK34405910, (01)00884838099876(21)DK32800867, (01)00884838099876(21)DK33603918, (01)00884838099876(21)DK33604048, (01)00884838099876(21)DK33904818, (01)00884838099876(21)DK34706539, (01)00884838099876(21)DK34405884, (01)00884838099876(21)DK33403219, (01)00884838099876(21)DK33603727, (01)00884838099876(21)DK34706371, (01)00884838099876(21)DK33402675, (01)00884838099876(21)DK33402648, (01)00884838099876(21)DK33604588, (01)00884838099876(21)DK33604264, (01)00884838099876(21)DK33402127, (01)00884838099876(21)DK34706378, (01)00884838099876(21)DK32801318, (01)00884838099876(21)DK33403095, (01)00884838099876(21)DK33603562, (01)00884838099876(21)DK34706181, (01)00884838099876(21)DK33604554, (01)00884838099876(21)DK33904888, (01)00884838099876(21)DK33402343, (01)00884838099876(21)DK40306696, (01)00884838099876(21)DK40306992, (01)00884838099876(21)DK33603488, (01)00884838099876(21)DK32800866, (01)00884838099876(21)DK34706255, (01)00884838099876(21)DK34706320, (01)00884838099876(21)DK34405767, (01)00884838099876(21)DK34706095, (01)00884838099876(21)DK33402405, (01)00884838099876(21)DK33603933, (01)00884838099876(21)DK33604442, (01)00884838099876(21)DK40306831, (01)00884838099876(21)DK33403181, (01)00884838099876(21)DK34405435, (01)00884838099876(21)DK34405878, (01)00884838099876(21)DK33905047, (01)00884838099876(21)DK33403263, (01)00884838099876(21)DK33402108, (01)00884838099876(21)DK33904987, (01)00884838099876(21)DK33402141, (01)00884838099876(21)DK33402149, (01)00884838099876(21)DK40306877, (01)00884838099876(21)DK33603419, (01)00884838099876(21)DK33402615, (01)00884838099876(21)DK33604419, (01)00884838099876(21)DK32801254, (01)00884838099876(21)DK32801299, (01)00884838099876(21)DK33604191, (01)00884838099876(21)DK33403177, (01)00884838099876(21)DK33904965, (01)00884838099876(21)DK34405697, (01)00884838099876(21)DK33402251, (01)00884838099876(21)DK33402899, (01)00884838099876(21)DK33604612, (01)00884838099876(21)DK33905057, (01)00884838099876(21)DK32801016, (01)00884838099876(21)DK33403251, (01)00884838099876(21)DK32801153, (01)00884838099876(21)DK40306893, (01)00884838099876(21)DK33403133, (01)00884838099876(21)DK33904707, (01)00884838099876(21)DK33402794, (01)00884838099876(21)DK34405477, (01)00884838099876(21)DK40306707 ,(01)00884838099876(21)DK32800977, (01)00884838099876(21)DK33603959, (01)00884838099876(21)DK33603543, (01)00884838099876(21)DK33402371, (01)00884838099876(21)DK34405486, (01)00884838099876(21)DK33403272, (01)00884838099876(21)DK33603742, (01)00884838099876(21)DK32801045, (01)00884838099876(21)DK33604374, (01)00884838099876(21)DK32801218, (01)00884838099876(21)DK33604349, (01)00884838099876(21)DK33905158, (01)00884838099876(21)DK33603443, (01)00884838099876(21)DK34706451, (01)00884838099876(21)DK33402451, (01)00884838099876(21)DK34405777, (01)00884838099876(21)DK34706063, (01)00884838099876(21)DK33402692, (01)00884838099876(21)DK34706448, (01)00884838099876(21)DK33604062, (01)00884838099876(21)DK32800961, (01)00884838099876(21)DK33604477, (01)00884838099876(21)DK33904802, (01)00884838099876(21)DK40307072, (01)00884838099876(21)DK32801156, (01)00884838099876(21)DK32801317, (01)00884838099876(21)DK32800916, (01)00884838099876(21)DK33603989, (01)00884838099876(21)DK33905142, (01)00884838099876(21)DK33904796, (01)00884838099876(21)DK33604177, (01)00884838099876(21)DK33603571, (01)00884838099876(21)DK33604137, (01)00884838099876(21)DK33604529, (01)00884838099876(21)DK33604398. .
Where was it sold?
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.
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