Recall Z-2172-2021 ยท CCW Laryngoscope, Rigid
Verathon, Inc.
GlideScope Go Monitors
| Date | Jul 1, 2021 |
| Status | Open, Classified |
| Reason | Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into the monitor resulting in loss of functionality. |
| Root cause | Device Design |
| Action | On 07/01/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via FedEx to customers informing them that the Recalling Firm has become aware of a variation in material thickness of a micro USB mounting plate can lead to insufficient sealing, resulting in the device failing to meet the labeled IP67 rating allowing fluid ingress and impact functionality of the monitor. Customers are instructed to: 1. Perform a visual inspection of monitor for fluid ingress, referring to figures 1 and 2 of the Notification Letter for visual examples of the failure to meet the IP67 rating. 2 |
| Quantity | 8,569 |
| 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, Denma |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.