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U.S. Department of Health and Human Services

Class 2 Device Recall ProSlate Speech Generation Devices

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 Class 2 Device Recall ProSlate Speech Generation Devicessee related information
Date Initiated by FirmOctober 11, 2021
Create DateDecember 28, 2021
Recall Status1 Open3, Classified
Recall NumberZ-0423-2022
Recall Event ID 89134
Product Classification System, communication, powered - Product Code ILQ
ProductAffected 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)
Code Information All units
FEI Number 1000136418
Recalling Firm/
Manufacturer		 Forbes Rehab Services Inc
181 Illinois Ave S
Mansfield OH 44905-2825
For Additional Information ContactSAME
419-589-7688
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionForbes 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 Commerce3065 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
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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