Recall Z-0686-2025— Philips North America Llc

Class II FDA medical device recall by Philips North America Llc, initiated 2024-11-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216. 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..

Recalling firm

Philips North America Llc

Classification

Class II

Status

Ongoing

Initiated

2024-11-20

Firm location

Cambridge, MA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.