FDA Medical Device Recalls (openFDA)
Philips North America Llc: Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
- Recall number
- Z-0686-2025
- Recalling firm
- Philips North America Llc
- Product
- Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
- Status
- Open, Classified
- Initiated
- 2024-11-20
- Posted
- 2024-12-17
- Terminated
- not on file
- Reason
- 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
- Under Investigation by firm
- Action
- 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.
- Quantity
- 4,811 units
- Distribution
- Nationwide distribution
- Lot, serial or model codes
- 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. .
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 3016618143
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28