| | Class 2 Device Recall Philips SmartHopping 2.0 AP 1.4 GHz |  |
| Date Initiated by Firm | November 20, 2024 |
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| Date Posted | December 17, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0686-2025 |
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| Recall Event ID |
95847 |
| Product Classification |
Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
|
| Product | Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216 |
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| Code Information |
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.
.
|
| FEI Number |
3016618143
|
Recalling Firm/
Manufacturer |
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
|
| For Additional Information Contact | Philips Customer Services
800-722-9377 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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. |
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| Quantity in Commerce | 4,811 units |
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| Distribution | Nationwide distribution |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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