Devices

Device Recall 83 Miniflex with accesory crate

Model / Serial
Serial numbers: 051305-J, 061705-E, 061605-F, and 061705-G.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide-The device was shipped to medical facilities in CA, GA, VA. and the UK.
Product Description
83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc.
Manufacturer
Custom Ultrasonics, Inc.
1 Event
- Recall of Device Recall 83 Miniflex with accesory crate

Manufacturer

Custom Ultrasonics, Inc.

Manufacturer Address
Custom Ultrasonics, Inc., 144 Railroad Dr, Ivyland PA 18974-1449
Manufacturer Parent Company (2017)
Custom Ultrasonics Inc
Source
USFDA

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