Verathon Inc.

Entity profile compiled from public source records

Public Record Profile Registrations: 1 510(k) filings: 0 Recalls: 3

Known Identifiers & Locations

FEI Numbers 3022472
Owner Operator Numbers 3022472
Locations Covered BOTHELL, WA, US

Registered Establishments (1)

Registration # Establishment Name Location Establishment Type(s) Action
3022472 Verathon Inc. BOTHELL, WA, US Manufacture Medical Device View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (3)

Recall # Product Description Initiation Date Status Action
Z-0003-2011 BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements. Reason: The BladderScan BVI 9600 with AortaScan devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function. 2010-08-23 Terminated View Details
Z-0004-2011 AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements Reason: The AortaScan AMI 9700 devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function. 2010-08-23 Terminated View Details
Z-0005-2011 BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively. Reason: The BladderScan BVM 9500 devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function. 2010-08-23 Terminated View Details

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