Z-0423-2022 Class II Ongoing
FDA device recall Z-0423-2022 was initiated by Forbes Rehab Services Inc on October 11, 2021 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 3065 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 5, 2022
- Initiation Date
- October 11, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3065 units
Product Description
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)
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
Distribution Pattern
US Nationwide distribution.
Code Information
All units