Devices

Device Recall HiRes90K Platinum Series Headpiece

Model / Serial
Model #AB-7300-001; Serial Numbers: 167419, 167420, 169309, 169310, 169311, 170983, 170984, 170985, 172709, 172710, 174272, 174274, 174275, 174298, 175139, 175988, 175989, 175990, 175991, 177627, 177628, 177629, 177630, 177631, 177671, 177672, 177673, 178494, 179252, 181303, 181304, 183489, 184405 and 184694
Product Classification
Ear, Nose, and Throat Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide
Product Description
HR90K Platinum Series Headpiece Model Number AB-7300-001 ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The HiRes90K headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. || The Harmony HiResolution Bionic Ear System and Clarion Multi-Strategy Cochlear Implant are cochlear implant systems designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss.
Manufacturer
Advanced Bionics LLC
1 Event
- Recall of Device Recall HiRes90K Platinum Series Headpiece

Manufacturer

Advanced Bionics LLC

Manufacturer Address
Advanced Bionics LLC, 12740 San Fernando Rd, Sylmar CA 91342-3728
Manufacturer Parent Company (2017)
Sonova Holding Ag
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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