Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0423-2022Class II

Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube...

Forbes Rehab Services Inc / initiated 2021-10-11 / Open, Classified

Forbes Rehab Services Inc began a recall of Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPOD... on . FDA classified it as Class II and gives the reason as "Warning Added: Using damaged cables or chargers, or charging when moisture is present, can cause fire, electric shock, injury, or damage to Speech Generating Device or other property". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-0423-2022
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Forbes Rehab Services Inc
Product
Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPOD Bluetooth Speaker accessory to the ProSlate Speech Generation Devices (including Proslate 13: B398PS130; Proslate 10: B398PS100; Proslate 8: B398PS080; Proslate 4: B398PS040)
Product code
ILQ System, Communication, Powered
Reason for recall
Warning Added: Using damaged cables or chargers, or charging when moisture is present, can cause fire, electric shock, injury, or damage to Speech Generating Device or other property
FDA root cause
Under Investigation by firm
Action
Forbes AAC emailed the safety advisory notice to all customers on 10/11/2021. Letter states reason for recall, health risk and action to take: To utilize the USB power adapter safely and reduce the possibility of heat-related injury or damage, plug the power adapter directly into a power outlet. Don t use the power adapter in wet locations, such as near a sink, bathtub, or shower stall, and don t connect or disconnect the power adapter with wet hands. Avoid prolonged skin contact with the charging cable and connector when the charging cable is connected to a power source because it may cause discomfort or injury. Sleeping or sitting on the charging cable or connector should be avoided. Stop using the power adapter and any cables if any of the following conditions exist The power adapter plug or prongs are damaged. The charge cable becomes frayed or otherwise damaged. The power adapter is exposed to excessive moisture, or liquid is spilled into the power adapter. The power adapter has been dropped, and its enclosure is damaged. Current production has added a label to the charger brick warning customers not to use the charger if the cable is broken or damaged. States: WARNING: DO NOT USE CHARGER WITH DAMAGED OR BROKEN CABLES.
Quantity in commerce
3065 units
Distribution
US Nationwide distribution.
Product codes and lots
All units

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0423-2022
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0423-2022Class IIOngoingVoluntary: Firm initiated