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Verathon Inc.

Last updated September 17, 2026

Information

Country: US
Address: 20001 North Creek Pkwy, BOTHELL, WA, 98011
Website: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3022472
DUNS Number: —

Catalogue (52)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
ScanPoint®	ScanPoint®	FDA UDI	Class II	Active
BladderScan®	i10™	FDA UDI	Class II	Active
BladderScan®	BVI 3000	FDA UDI	Class II	Unknown
BladderScan®	Prime Plus™	FDA UDI	Class II	Active
BladderScan®	Prime	FDA UDI	Class II	Active
BladderScan®	Prime	FDA UDI	Class II	Unknown
BladderScan®	BVI 6000 Series	FDA UDI	Class II	Active
BladderScan®	BVI 9400	FDA UDI	Class II	Unknown
BladderScan®	BVI 3000	FDA UDI	Class II	Unknown
BladderScan®	Prime	FDA UDI	Class II	Active
BladderScan®	i10™	FDA UDI	Class II	Active
BladderScan®	BVI 3000	FDA UDI	Class II	Unknown
BladderScan®	BVI 6000 Series	FDA UDI	Class II	Active
BladderScan®	i10™	FDA UDI	Class II	Active
BladderScan®	BVI 9400	FDA UDI	Class II	Unknown
BladderScan®	i10™	FDA UDI	Class II	Active
BladderScan®	BVI 6000 Series	FDA UDI	Class II	Active
BladderScan®	Prime Plus™	FDA UDI	Class II	Unknown
BladderScan®	BVI 6000 Series	FDA UDI	Class II	Unknown
BladderScan®	Prime	FDA UDI	Class II	Active
BladderScan®	BVI 3000	FDA UDI	Class II	Unknown
BladderScan®	i10™	FDA UDI	Class II	Active
BladderScan®	BVI 3000	FDA UDI	Class II	Unknown
ScanPoint®	Docking Station	FDA UDI	Class II	Active
BladderScan®	i10™	FDA UDI	Class II	Active
BladderScan®	BVI 3000	FDA UDI	Class II	Unknown
BladderScan®	BVI 6000 Series	FDA UDI	Class II	Active
BladderScan®	Tissue-Equivalent Phantom	FDA UDI	Class II	Active
BladderScan®	BVI 3000	FDA UDI	Class II	Active
BladderScan®	BVI 9400	FDA UDI	Class II	Unknown
BladderScan®	BVI 9400	FDA UDI	Class II	Unknown
BladderScan®	BVI 3000	FDA UDI	Class II	Unknown
BladderScan®	BVI 3000	FDA UDI	Class II	Unknown
BladderScan®	Prime	FDA UDI	Class II	Unknown
BladderScan®	i10™	FDA UDI	Class II	Active
BladderScan®	BVI 3000	FDA UDI	Class II	Unknown
BladderScan®	BVI 6000 Series	FDA UDI	Class II	Active
BladderScan®	BVI 9400	FDA UDI	Class II	Unknown
BladderScan®	Prime	FDA UDI	Class II	Unknown
BladderScan®	BVI 9400	FDA UDI	Class II	Unknown
BladderScan®	Pediatric Phantom	FDA UDI	Class II	Active
BladderScan®	Training Phantom	FDA UDI	Class II	Unknown
BladderScan®	BVI 6000 Series	FDA UDI	Class II	Active
BladderScan®	Prime Plus™	FDA UDI	Class II	Unknown
BladderScan®	BVI 9400	FDA UDI	Class II	Unknown
BladderScan®	BVI 6000 Series	FDA UDI	Class II	Active
BladderScan®	Prime	FDA UDI	Class II	Active
BladderScan®	i10™	FDA UDI	Class II	Active
BladderScan®	BVI 9400	FDA UDI	Class II	Unknown
BladderScan®	BVI 6000 Series	FDA UDI	Class II	Active

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FDA Recalls (19)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 29, 2024	Z-2022-2024	—	open, classified	Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices.
Apr 29, 2024	Z-2021-2024	—	open, classified	Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices.
Jul 1, 2021	Z-2172-2021	—	open, classified	Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into the monitor resulting in loss of functionality.
Sep 29, 2020	Z-0531-2021	—	terminated	Due to a change in handle material and process, probe handle may crack.
Jun 5, 2020	Z-2476-2020	—	terminated	When video laryngoscopy system users apply, twisting motions while connecting the blade in the HDMI port, or excessive torsion to the connection port, this force is transferred to the HDMI PCB, which may result in video synchronization interruption, loss of live image/blank screen, no cameras connected monitor warning, may present risk to patients, in which time to intubation is more critical.
Mar 31, 2019	Z-1471-2020	—	terminated	A typographical error in the Operations & Maintenance Manual incorrectly identifies the use of low level disinfection for the reusable video laryngoscope, specifically for the Titanium Blades.
Mar 3, 2017	Z-1852-2017	—	terminated	Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades)).
Jan 29, 2016	Z-1035-2016	—	terminated	The firm has become aware of the potential for disruption (flickering) in the video laryngoscopy image when GlideScope Titanium SU laryngoscope blades are in use. Video "flickering" appears as the intermittent break-up of the on-screen video image, appearing as either distorted horizontal or vertical bars of displaced video signal.
Nov 30, 2015	Z-1091-2016	—	terminated	The firm is providing customers with an updated Operations and Maintenance Manual for each of the BladderScan BVI 9600 and AortaScan AMI 9700 devices. The updated Operations and Maintenance Manuals clarify that these devices should not be used for the screening, detection, or diagnosis of abdominal aortic aneurysms (AAAs).
Nov 30, 2015	Z-0421-2016	—	terminated	Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. The potential for blade separation may not be readily visible during routine inspection before or after intubation.
Nov 30, 2015	Z-0420-2016	—	terminated	Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. The potential for blade separation may not be readily visible during routine inspection before or after intubation.
Apr 13, 2015	Z-0811-2016	—	terminated	Verathon has revised the Operations and Maintenance Manual (OMM) to specifically state compatibility limitations of the reusable video laryngoscope Blade validated through simulated use cycles, such that exceeding this number of cycles in the specific chemical agent may affect the potential life of the product.
May 8, 2013	Z-1558-2013	—	terminated	Verathon GlideScope Reusable GVL and AVL Blades are being recalled due to the potential risk of premature failure/breakage of the blade tip that may not be readily visible during routine inspection before or after intubation.
Oct 25, 2012	Z-0478-2013	—	terminated	Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to potential cracking.
Sep 20, 2010	Z-0143-2011	—	terminated	Incorrect programming causes QuickPrint to fail to recognize the communication Cradles. As a result, ScanPoint Communications Cradles could not communicate with ScanPoint Online Tool while using the QuickPrint interface. This will affect the transfer of exams and device calibration through QuickPrint interface.
Aug 23, 2010	Z-0003-2011	—	terminated	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.
Aug 23, 2010	Z-0004-2011	—	terminated	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.
Aug 23, 2010	Z-0005-2011	—	terminated	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.
May 18, 2009	Z-1939-2009	—	terminated	Three specific issues are being addressed: 1. Calculation and use of an incorrect year in dates after 12/31/2009. 2. Double scans, continuous scans, and double printing. 3. Calibration sensitivity.