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Open, Classified

GlideScope Go Monitors

FDA Recall Z-2172-2021 · Posted None

Recalling FirmVerathon, Inc.
Recall StatusOpen, Classified
Product CodeCCW
Date Initiated2021-07-01
Product Quantity8,569

Reason for Recall

Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into the monitor resulting in loss of functionality.

Firm 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. Based on the visual inspection of their device(s), do one of the following: -If their Monitor has no fluid ingress or they do not wish to return their affected product, complete the attached Recall Response Form by indicating no or 0 in the text box and return the form by email to [email protected]. Or -If their Monitor has fluid ingress and they would like these units serviced (similar to Figures 1 and 2) complete the attached Recall Response Form. They will need to indicate, by number, the count of Monitors that require service in the text box and return the form by email to [email protected]. The Recalling Firm's Customer Care will contact them to make arrangements to replace their monitor. The firm is implementing a change in the design for the monitor micro-USB mounting plate to reduce the variation in the thickness in order to meet the IP67 rating. Any questions - contact the Recalling Firm's Representative or Customer Care at [email protected]

Root Cause

Device Design

Distribution Pattern

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, Denmark, Estonia, Falkland Island (Malvinas), France, Germany, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Kuwait, Luxembourg, Malaysia, New Zealand, Oman, Papua New Guinea, Philippines, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, The Netherlands, United Arab Emerita, and United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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