Devices

Device Recall Isotechnology, Isobalance System

Model / Serial
Serial numbers: 07-001 through 07-030.
Product Classification
Ear, Nose, and Throat Devices
Device Class
Unclassified
Implanted device?
No
Distribution
Class II Recall - Nationwide Distribution --- including states of CA, VA, MA and TX.
Product Description
Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to determine possible inner ear problems.
Manufacturer
Acacia Engineered Products LLC
1 Event
- Recall of Device Recall Isotechnology, Isobalance System

Manufacturer

Acacia Engineered Products LLC

Manufacturer Address
Acacia Engineered Products LLC, 1108 Harpeth Industrial Ct, Franklin TN 37064-2224
Manufacturer Parent Company (2017)
Acacia Engineered Products
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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