Skytron, Llc
5085 Corporate Exchange Blvd SE, Grand Rapids, MI, US
Registered product codes
24 product codes
Recent MDR events
63 on file
- TV-3 HANDLE CAMERA AURORA 3 AND FOUR SERIESJun 11, 2026Malfunction25470602
- AURORA SURGICAL LIGHT SERIESFeb 19, 2026Malfunction24387614
- EZ SLIDEFeb 2, 2026Malfunction24229072
- SKYTRONOct 6, 2025MalfunctionMW5176921
- ELITESep 17, 2025Malfunction23073031
- SKYTRON ULTRASLIDE 3600B SURGICAL TABLEAug 6, 2025MalfunctionMW5174133
- SKYTRON ULTRASLIDE 3600B SURGICAL TABLEAug 6, 2025MalfunctionMW5174134
- ULTRASLIDE 3600BJun 30, 2025Malfunction22352620
- SKYTRON LLC OR TABLESMay 15, 2025InjuryMW5170430
- STELLAR XL SURGICAL LIGHTOct 28, 2024InjuryMW5161732
Recalls
2 on file
- Open, ClassifiedAug 28, 2023
When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Originally, the root cause was thought to be confined to Bluetooth/wireless communications between the control pendant and the surgical table. However, during investigation, Mizuho discovered that the failure could be replicated even in wired mode if communication between the pendant and table were somehow interrupted. The root cause appears to be: if communication between the controller and table is interrupted while a button is pressed, the table does not know if/when a button is released. This occurs in wireless or wired mode.
View FDA record ↗ - Open, ClassifiedAug 28, 2023
When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Originally, the root cause was thought to be confined to Bluetooth/wireless communications between the control pendant and the surgical table. However, during investigation, Mizuho discovered that the failure could be replicated even in wired mode if communication between the pendant and table were somehow interrupted. The root cause appears to be: if communication between the controller and table is interrupted while a button is pressed, the table does not know if/when a button is released. This occurs in wireless or wired mode.
View FDA record ↗
Compliance history
Matched by FEI 1825014.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
1 on file
Import refusals
0 on file
No import refusals on file for this FEI number.