Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
This recall is currently active, issued December 17, 2024. It was issued by Philips North America Llc.
- Company
- Philips North America Llc
- Recall Initiated
- November 20, 2024
- Posted
- December 17, 2024
- Recall Number
- Z-0686-2025
- Quantity
- 4,811 units
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide distribution
Lot / Code Info
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. .
Root Cause
Under Investigation by firm
Action Taken
Consignees were notified on about 11/20/2024 via certified mail. Consignees were instructed to identify affected units, share the communication with clinical staff, and place the Urgent Medical Device Correction with the documentation of the Philips Smart-hopping 2.0 AP 1.4 GHz and associated devices. A Philips representative will contact customers to arrange a software upgrade to E.19.02 (5.0.19.02) or greater to correct the issues. Distributors were instructed to contact customers and provide the Medical Device Correction to each.