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U.S. Department of Health and Human Services

Class 2 Device Recall tobii dynavox

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  Class 2 Device Recall tobii dynavox see related information
Date Initiated by Firm December 14, 2017
Create Date April 03, 2018
Recall Status1 Terminated 3 on December 11, 2019
Recall Number Z-1304-2018
Recall Event ID 79433
Product Classification System, communication, powered - Product Code ILQ
Product Dynavox T10 Speech Generating Device ( including Batteries)
Code Information TS1308 TS1411  Part Numbers: T10: 750394  Date Codes are part of the device s unique Serial Number and represent the year and month the device was manufactured.
Recalling Firm/
Manufacturer		 Dynavox Systems Llc
2100 Wharton St Ste Ste 400
Pittsburgh PA 15203-1691
Manufacturer Reason
for Recall		 The battery is integral to the device. If the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and the battery will expire. The battery may out-gas which may be described as swelled or puffed, as gas is trapped inside the pack surrounding the cells. This battery may cause the device case to separate a small amount.
FDA Determined
Cause 2		 Component design/selection
Action On February 26, 2018 an URGENT MEDICAL RECALL LETTER was issued to customers with the subject line listing the serial number specific to that customer along with the date of purchase. The letter informs customers of the issue and instructs customers to return product to one of their facilities to have the product repaired until an RA. Questions or concerns can be directed to 1-800-344-1778, Press 1 and then Press 2.
Quantity in Commerce 4615
Distribution Nationally
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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