Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max....

FDA Device Recall #Z-1569-2020 — Class II — March 5, 2020

Recall Summary

Recall Number Z-1569-2020
Classification Class II — Moderate risk
Date Initiated March 5, 2020
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Skytron, Div. The KMW Group, Inc
Location Grand Rapids, MI
Product Type Devices
Quantity 43 units

Product Description

Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1

Reason for Recall

Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.

Distribution Pattern

AZ, CO, GA, IL, MI, MN, NJ, PA, VA, VT

Lot / Code Information

Serial Numbers: 1507T719-00-0-0087 1509T719-00-0-0142 1509T719-00-0-0144 1509T719-00-0-0139 1507T719-00-0-0085 1509T719-00-0-0135 1508T719-00-0-0115 1508T719-00-0-0116 1508T719-00-0-0119 1508T719-00-0-0120 1507T719-00-0-0074 1508T719-00-0-0129 1508T719-00-0-0121 1508T719-00-0-0123 1508T719-00-0-0124 1508T719-00-0-0125 1508T719-00-0-0126 1509T719-00-0-0132 1509T719-00-0-0146 1507T719-00-0-0103 1507T719-00-0-0104 1507T719-00-0-0053 1507T719-00-0-0054 1507T719-00-0-0055 1507T719-00-0-0056 1507T719-00-0-0058 1507T719-00-0-0059 1507T719-00-0-0061 1507T719-00-0-0062 1507T719-00-0-0063 1507T719-00-0-0064 1508T719-00-0-0127 1508T719-00-0-0128 1510T719-00-0-0153 1510T719-00-0-0154 1510T719-00-0-0157 1510T719-00-0-0160 1510T719-00-0-0166 1508T719-00-0-0118 1510T719-00-0-0159 1508T719-00-0-0114 1508T719-00-0-0117 1508T719-00-0-0122

Other Recalls from Skytron, Div. The KMW Group, Inc

Recall # Classification Product Date
Z-1309-2022 Class II Product Name: GCX Channel Mounting Accessory M... Jun 2, 2022
Z-1861-2021 Class II Skyton Bracket Flatscreen, Revision 2 & 3-The F... May 11, 2021
Z-0071-2021 Class II VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Sin... Sep 11, 2020
Z-0109-2021 Class II SkyVision SDS System - Video Integration Model... Mar 10, 2020
Z-1779-2019 Class II Skytron Integrity 270 Steam Sterilizer and Skyt... Apr 18, 2019

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.