Verathon, Inc.
Medical device manufacturer in Bothell, WA.
5510(k) clearances
0PMA approvals
19recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K172356 | BladderScan Prime PLUS SystemIYO · Traditional | 09/15/2017SE |
| K153101 | BladderScan Prime SystemIYO · Traditional | 11/19/2015SE |
| K090214 | Verathon Inc. Bladderscan BVM 9500 UltrasoundIYO · Abbreviated | 03/13/2009SE |
| K082456 | Verathon Inc. Bladderscan Ultrasound System, Model Bvi 9600IYO · Abbreviated | 12/01/2008SE |
| K071217 | Bladderscan Bvi 9400 UltrasoundIYO · Traditional | 05/17/2007SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2022-2024 Class II | Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software…Due to software issues, their is the potential for loss of image or a degradation of the image when using… | 04/29/2024Open, Classified |
| Z-2021-2024 Class II | Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product…Due to software issues, their is the potential for loss of image or a degradation of the image when using… | 04/29/2024Open, Classified |
| Z-2172-2021 Class III | GlideScope Go MonitorsHandheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into the monitor… | 07/01/2021Open, Classified |
| Z-0531-2021 Class II | BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for…Due to a change in handle material and process, probe handle may crack. | 09/29/2020Terminated |
| Z-2476-2020 Class I | GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope…When video laryngoscopy system users apply, twisting motions while connecting the blade in the HDMI port, or… | 06/05/2020Terminated |
| Z-1471-2020 Class II | GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03A typographical error in the Operations & Maintenance Manual incorrectly identifies the use of low level… | 03/31/2019Terminated |
| Z-1852-2017 Class II | It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part…Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device… | 03/03/2017Terminated |
| Z-1035-2016 Class I | GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope…The firm has become aware of the potential for disruption (flickering) in the video laryngoscopy image when… | 01/29/2016Terminated |
| Z-1091-2016 Class II | BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451.…The firm is providing customers with an updated Operations and Maintenance Manual for each of the… | 11/30/2015Terminated |
| Z-0421-2016 Class II | GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116…Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to… | 11/30/2015Terminated |
| Z-0420-2016 Class II | GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001…Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to… | 11/30/2015Terminated |
| Z-0811-2016 Class II | GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The…Verathon has revised the Operations and Maintenance Manual (OMM) to specifically state compatibility… | 04/13/2015Terminated |
| Z-1558-2013 Class I | GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable…Verathon GlideScope Reusable GVL and AVL Blades are being recalled due to the potential risk of premature… | 05/08/2013Terminated |
| Z-0478-2013 Class I | The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a…Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to potential… | 10/25/2012Terminated |
| Z-0143-2011 | The label (which is affixed to ScanPoint Communications Cradle) states: "...VERATHON…Incorrect programming causes QuickPrint to fail to recognize the communication Cradles. As a result… | 09/20/2010Terminated |
| Z-0005-2011 | BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy…The BladderScan BVM 9500 devices may experience the loss of a factory installed software configuration file… | 08/23/2010Terminated |
| Z-0004-2011 | AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects…The AortaScan AMI 9700 devices may experience the loss of a factory installed software configuration file… | 08/23/2010Terminated |
| Z-0003-2011 | BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with…The BladderScan BVI 9600 with AortaScan devices may experience the loss of a factory installed software… | 08/23/2010Terminated |
| Z-1939-2009 | The BladderScan BVI 9400 is a portable ultrasound instrument that provides a noninvasive…Three specific issues are being addressed: 1. Calculation and use of an incorrect year in dates after… | 05/18/2009Terminated |