Recall Z-2022-2024 ยท CCW Laryngoscope, Rigid
Verathon, Inc.
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
| Date | Jun 4, 2024 (initiated Apr 29, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | On April 30, 2024, Verathon issued "Urgent Medical Device Correction" notification via FedEx. Verathon asked consignees to take the following actions: 1. Plug your GlideScope Core 15 or Core 15 FHD into the power supply and connect to a hospital-grade power outlet. 2. Use the enclosed USB drive with the corrective software upgrade and related instructions to upgrade your GlideScope Core 15 or Core 15 FHD monitor(s) (approximately 5-7 minutes for the upgrade). 3.Verify the software version on the Administrative Settings tab. OR 4.Contact Verathon Customer Care to contact your Territory |
| Quantity | 1706 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.