Z-2348-2008

Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to...

Name: Z-2348-2008 Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to...
Creator: Acacia Engineered Products LLC
Published: 2008-07-09
License: https://open.fda.gov/license/

Acacia Engineered Products LLC / initiated 2008-07-09 / Terminated

FDA source

Acacia Engineered Products LLC began a recall of Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to determine possible inner ear problems on 2008-07-09. The reason FDA records is "The firm distributed an unapproved medical device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2348-2008
Status: Terminated
Initiated: 2008-07-09
Posted: 2008-09-17
Terminated: 2010-02-17
Recalling firm: Acacia Engineered Products LLC
Product: Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to determine possible inner ear problems.
Product code: LXV Apparatus, Vestibular Analysis
Reason for recall: The firm distributed an unapproved medical device.
FDA 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 in commerce: 24
Distribution: Class II Recall - Nationwide Distribution --- including states of CA, VA, MA and TX.
Product codes and lots: Serial numbers: 07-001 through 07-030.

Product code LXV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)