CLASS II Device recall · Reported 8 Jun 2016 · FDA Enforcement Report
Ergon III Series Skyboom Monitor Bracket recalled
Skytron Div. The KMW Group is recalling Ergon III Series Skyboom Monitor Bracket, distributed in Georgia, Illinois, New Jersey, Utah, Virginia, Vermont. The recall was initiated on 28 Mar 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1871-2016
- FDA event ID
- 73704
- Recalling firm
- Skytron Div. The KMW Group, Grand Rapids, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Mar 2016
- FDA classified
- 31 May 2016
- Reported
- 8 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 28 Mar 2016 | Recall initiated by company | |
| 31 May 2016 | Classified by FDA | +64 days |
| 8 Jun 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size
Where it was distributed
Worldwide distribution. US states: VA, VT, UT, GA, NJ, and IL; Japan.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model Number(s): 3FCM1; Manufactured Date: September 2015; Serial Numbers 1507T719-00-0-0074, 1507T719-00-0-0091, 1507T719-00-0-0095, 1507T719-00-0-0096, 1507T719-00-0-0102, 1507T719-00-0-0107, 1508T719-00-0-0129, 1507T719-00-0-0087, 1507T719-00-0-0069, 1507T719-00-0-0103, 1507T719-00-0-0104, 1507T719-00-0-0066, 1507T719-00-0-0072, 1507T719-00-0-0073, 1507T719-00-0-0075, 1507T719-00-0-0088, 1507T719-00-0-0101, 1507T719-00-0-0108, 1507T719-00-0-0112, 1507T719-00-0-0113, 1507T719-00-0-0090, 1507T719-00-0-0097, 1507T719-00-0-0099, and 1507T719-00-0-0100
Where was it sold?
Worldwide distribution. US states: VA, VT, UT, GA, NJ, and IL; Japan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Skytron Div. The KMW Group
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | GCX Channel Mounting Accessory recalled by Skytron, Div. The KMW Group | Skytron Div. The KMW Group | Other | Nationwide |
| Device | CLASS II | Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 recalled | Skytron Div. The KMW Group | Device Malfunction | Nationwide |
| Device | CLASS II | SkyVision SDS System - Video Integration recalled | Skytron Div. The KMW Group | Device Malfunction | Nationwide |
| Device | CLASS II | Vgdf-sky (R4-010-06) Vga TO Fiber Converter-Single Format recalled | Skytron Div. The KMW Group | Device Malfunction | 5 states |
| Device | CLASS II | Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen recalled | Skytron Div. The KMW Group | Device Malfunction | 10 states |
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