—#211357

Product

Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216

FDA product code: MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
Affected 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. .

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: Nationwide distribution

Timeline

Recall initiated: 2024-11-20
Posted by FDA: 2024-12-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211357. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.