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U.S. Department of Health and Human Services

Class 2 Device Recall Isotechnology, Isobalance System

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  Class 2 Device Recall Isotechnology, Isobalance System see related information
Date Initiated by Firm July 09, 2008
Date Posted September 17, 2008
Recall Status1 Terminated 3 on February 17, 2010
Recall Number Z-2348-2008
Recall Event ID 48990
Product Classification Vestibular analysis apparatus - Product Code LXV
Product Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to determine possible inner ear problems.
Code Information Serial numbers: 07-001 through 07-030.
Recalling Firm/
Manufacturer		 Acacia Engineered Products LLC
1108 Harpeth Industrial Ct
Franklin TN 37064-2224
For Additional Information Contact Eric J. Johnson
615-202-9370
Manufacturer Reason
for Recall		 The firm distributed an unapproved medical device.
FDA Determined
Cause 2		 PMA
Action On July 9, 2008 the firm issued a Device Recall Notification letter to its consignees by letter on July 9, 2008 by US mail. The recall notification was directed to the end users of the units requesting the return of all units. In the event of a non-responding consignee, the firm will make additional efforts to contact the individual via certified return receipt mail or other form of notification requiring a signature. Follow up direct contact through telephone will also be used. If you have any questions contact Eric Johnson at (615) 202-9370.
Quantity in Commerce 24
Distribution Class II Recall - Nationwide Distribution --- including states of CA, VA, MA and TX.
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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