Recall Z-2348-2008 ยท LXV Apparatus, Vestibular Analysis
Acacia Engineered Products LLC
Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to determine possible inner ear problems.
| Date | Sep 17, 2008 (initiated Jul 9, 2008) |
| Status | Terminated |
| Reason | The firm distributed an unapproved medical device. |
| Root cause | 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 | 24 |
| Distribution | Class II Recall - Nationwide Distribution --- including states of CA, VA, MA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.