Skytron, LLC
Grand Rapids, MI, US
Skytron, LLC appears in FDA device records in Grand Rapids, MI. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 24 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Skytron, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Skytron, Div. the Kmw Group, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 19 510(k) clearances for Skytron, LLC between 1981 and 2007. The busiest year on record is 1985, with 4. The most recent is 2007, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1985 | 4 |
| 1987 | 2 |
| 1990 | 3 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 1 |
| 1999 | 1 |
| 2000 | 1 |
| 2002 | 1 |
| 2007 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K071698 | AURORA LED SERIES SURGICAL LIGHTS | FSY | Substantially Equivalent | |
| K021585 | STELLAR SERIES SURGICAL LIGHTS WITH HERMES | FSY | Substantially Equivalent | |
| K002463 | STELLAR | FSY | Substantially Equivalent | |
| K992090 | MILLENNIUM GOLD | FSY | Substantially Equivalent | |
| K950192 | SKYTRON SKYBOOM SERIES | FQO | Substantially Equivalent | |
| K940616 | SKYTRON ELITE 3500 TABLE | GDC | Substantially Equivalent | |
| K933564 | SKYTRON EXAM LIGHT | KZF | Substantially Equivalent | |
| K926045 | SKYTRON LIFE ISLAND 21 | FNM | Substantially Equivalent | |
| K915285 | SKYTRON INFINITY SERIES SURGICAL LIGHTS | FSY | Substantially Equivalent | |
| K900472 | SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI | HBN | Substantially Equivalent | |
| K900211 | SKYTRON UNIVERSE SERIES SURGICAL LIGHTS | FSY | Substantially Equivalent | |
| K900290 | SKYTRON MODEL 1100 AND MODEL 142 | JEA | Substantially Equivalent | |
| K873478 | SKYTRON MODEL 130 SURGICAL TABLE | FWY | Substantially Equivalent | |
| K870045 | SKYTRON MODEL 610-2 | INX | Substantially Equivalent | |
| K853480 | SKYTRON ELITE 6000 & 6001 SURGICAL TABLES | GDC | Substantially Equivalent | |
| K853479 | SKYTRON ELITE 300 SURGERY TABLE | FWW | Substantially Equivalent | |
| K851830 | SKYTRON ELITE 7000 MICRO-SURGERY TABLE | GDC | Substantially Equivalent | |
| K851829 | SKYTRON ELITE 3100 SURGICAL TABLE | GDC | Substantially Equivalent | |
| K811311 | SKYTRON ELITE SURGICAL TABLES | GBC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1825014 | 1825014 | Skytron, LLC | 5085 Corporate Exchange Blvd SE, Grand Rapids, MI 49512 US | 2026 | and 14 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FYDApparatus, Exhaust, Surgical
- IMYArmboard, Wheelchair
- NNWBag, Urine Collection, Leg, For External Use, Non-Sterile
- INXBed, Air Fluidized
- KQMCamera, Surgical And Accessories
- FWCCamera, Television, Surgical, With Audio
- HBNChair, Neurosurgical
- FLGCleaner, Ultrasonic, Medical Instrument
- KZFDevice, Medical Examination, Ac Powered
- MECDisinfector, Medical Devices
- PUIDrape, Surgical, Exempt
- GBCLamp, Surgical, Incandescent
- FTALight, Surgical, Accessories
- FSYLight, Surgical, Ceiling Mounted
- FSSLight, Surgical, Floor Standing
- FNMMattress, Air Flotation, Alternating Pressure
- OUGMedical Device Data System
- FOXStand, Infusion
- FLESterilizer, Steam
- LWGSurgical Table Cushion
- LMDSystem, Digital Image Communications, Radiological
- LLZSystem, Image Processing, Radiological
- MMZTable, Cystometric, Electric
- FQOTable, Operating-Room, Ac-Powered
- GDCTable, Operating-Room, Electrical
- FWYTable, Operating-Room, Non-Electrical
- FWWTable, Operating-Room, Pneumatic
- JEATable, Surgical With Orthopedic Accessories, Ac-Powered
- GAZTubing, Noninvasive
- LHCWarmer, Irrigation Solution
- LGZWarmer, Thermal, Infusion Fluid
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2470-2023 | GS70H Salus Surgical Table, Product Code 18-071-70 | 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. | Class II | Open, Classified | |
| Z-2469-2023 | GS70 Salus Surgical Table, Product Code 18-070-70 | 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. | Class II | Open, Classified | |
| Z-1309-2022 | Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A | Under certain circumstances, the mounting screws may loosen or pull out from the attachment point on the Ergon 3 boom when the GCX Channel Mounting Accessory was used with the VST clamp as a monitor mount on the boom. | Class II | Open, Classified | |
| Z-1861-2021 | Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32 | Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time and eventually detach from the baseplate, result in the display interface dismounting from its attachment point, causing injury to patients or staff | Class II | Open, Classified | |
| Z-0071-2021 | VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Model: VGDF-SKY (version 2). For communication and visual image management in the operating room suite. | VGDF (VGA) Faceplate failure results in failure of video signal for SkyVision Linx 300, a secondary display. Video would continue on the primary source device display | Class II | Terminated | |
| Z-0109-2021 | SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained video switching and control unit for use in the operating room. | Intermittent failure of a signal being sent to a monitor from the touch panel display causing the displaying monitor to go Blank and the touch panel to display a Blank image when reviewing the target display. If this issue were to happen during a case, cause increase risk to patient due to hospital losing the visual image. | Class II | Terminated | |
| Z-1569-2020 | Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1 | 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. | Class II | Open, Classified | |
| Z-1779-2019 | Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry | Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure | Class II | Terminated | |
| Z-1844-2016 | EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General Purpose Surgical Table Skytron EZ Slide Operating Table General Purpose Surgical Table | The potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. If a table is found to have these incorrectly manufactured parts, it is possible for the tables elevation column slide cap to become detached from the elevation column and could result in the loss of control of the table top and injury to the patient or staff. | Class II | Terminated | |
| Z-1871-2016 | Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size | 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. | Class II | Terminated | |
| Z-0655-2016 | Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms | The hardware that holds the VESA plate and the display interface / monitor to the bracket may fail causing the display interface to fall from the bracket. Over time and with use the threaded rod hardware material can weaken and detach from the bracket. A display interface falling from its mounting location may result in injury to the patient or provider. | Class II | Terminated | |
| Z-0534-2007 | Skytron Infinity Series surgical light with triple lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Model IN302222EL, IF302222-B, IN30AR2222EL and IN30TV2222EL. (note only the 22'' lightheads are affected). | If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount. | Terminated | ||
| Z-0533-2007 | Skytron Infinity Series surgical light with dual lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IN3022EL and IF3022EL. (note only the 22'' lighthead is affected). | If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount. | Terminated | ||
| Z-0532-2007 | Skytron Infinity Series surgical light with triple lightheads, 5 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF222222-B, IF222222EL and IN222222EL. | If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount. | Terminated | ||
| Z-0531-2007 | Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in 1 - 22' lighthead and 8 bulbs in 1 - 30' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Model IF3022B. (note only the 22'' lighthead is affected.) | If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount. | Terminated | ||
| Z-0530-2007 | Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF2222, IF2222-B, IF2222B/PT, IF2222EL and IN2222EL. | If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount. | Terminated | ||
| Z-0529-2007 | Skytron Infinity Series surgical light, 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF22, IF22B, IF22LH, IF22LHH-B, IF22M-S, IN22, IN22EL, IN22LH and IF22(EL). | If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount. | Terminated | ||
| Z-0528-2007 | Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF545454 and IF545454EL. | If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount. | Terminated | ||
| Z-0527-2007 | Skytron Infinity Series surgical light with dual lightheads, 4 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF5454 and IF5454EL. | If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount. | Terminated | ||
| Z-0526-2007 | Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S. | If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount. | Terminated | ||
| Z-0525-2007 | Skytron Infinity Series (also called Astro series) minor surgery light with dual lightheads, 3 bulbs in each of 2 - 19' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IN1919 and IN1919EL and IN1919EL/PT. | If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount. | Terminated | ||
| Z-0524-2007 | Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S. | If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount. | Terminated | ||
| Z-1497-06 | Skytron General Purpose Surgical Table, battery model; Model 6600B, Dist. by Skytron, Grand Rapids, MI. | The release levers can inadvertently release under load while the leg section is positioned at a ninety degree angle causing the leg section to drop. | Terminated | ||
| Z-1496-06 | Skytron General Purpose Surgical Table; Model 6600, Dist. by Skytron, Grand Rapids, MI. | The release levers can inadvertently release under load while the leg section is positioned at a ninety degree angle causing the leg section to drop. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain