Medical device recalls Moderate risk

Philips North America Llc recalls Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216

Recall date
November 20, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0686-2025
FDA classification
Class II
Brand / firm
Philips North America Llc
Sold / distributed
Nationwide distribution

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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