Bothell, WA, United States
Verathon, Inc. recalls
5 recalls recorded since 2018, most recently on 29 April 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)2
Terminated or completed3
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 29 April 2024
- Reason
- 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.
- Distribution
- US: AK AL AR AZ CA CO CT DC FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK ON OR PA QLD RI SC SD TN TX UT VA VIC WA WI WV WY OUS: Hong Kong, Indonesia, Saudi Arabia
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2022-2024, Z-2021-2024
- Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software Version: Core 15 FHD v1.7 and earlier Product Description: Serialized Monitor
- Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor
Ongoing Class III Medical devices
- Recall started
- 1 July 2021
- Reason
- Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into the monitor resulting in loss of functionality.
- Distribution
- U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. O.U.S.: Australia, Brunei Darussalam, Canada, Czech Republic, Den
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2172-2021
Terminated Class II Medical devices
- Recall started
- 29 September 2020
- Terminated
- 29 June 2022
- Reason
- Due to a change in handle material and process, probe handle may crack.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WI, WV and WY. The countries of Austrailia, Belgium, Canada, France, Germany
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0531-2021
- BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.
Terminated Class I Medical devices
- Recall started
- 5 June 2020
- Terminated
- 22 April 2024
- Reason
- 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.
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Australia and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2476-2020
- GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core OneTouch Cables (Reusable Device) is ancillary equipment used with the Core 10 and Cor
Terminated Class II Medical devices
- Recall started
- 31 March 2019
- Terminated
- 14 December 2021
- Reason
- 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.
- Distribution
- US: RI, IL, FL, SD, NY, MD, CA, OH, LA, AZ, GA, WA, OK, NC, AL, PA, TN, NJ, NV, MI, OR, TX, NM, VA, UT, NE, WI, CO, AR, MN, CT, ND, and KS. OUS: Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1471-2020
- GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.