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

FDA device recall Z-0686-2025 · posted 2024-12-17 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

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.

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MHX

Quantity affected

4,811 units

Distribution

Nationwide distribution

Date initiated

2024-11-20

Date posted

2024-12-17

Location

Cambridge, MA