Skytron, Div. the Kmw Group, Inc.
United StatesFDA applicant, unverified
- Devices
- 19
- FDA recalls
- 222 ongoing since 2021 (3 open in total)
At a glance
Market reach
- United States
- FDA recalls
What Skytron, Div. the Kmw Group, Inc. makes
Skytron manufactures surgical tables, including the Skytron Elite 300, Model 130, Elite Series, Model 3100, and SkyBoom Series, designed for operating room use. Their product line also includes surgical lighting systems such as the Universe Series, Infinity Series, and Stellar Series with Hermes, as well as the Model 610-2 and Model 1100/142. Additional offerings include the Life Island 21, a specialized surgical support device.
The company’s devices are classified under FDA categories Class I and Class II, with regulatory records supported by 510(k) clearances. These products are listed in the U.S. under the FDA’s 510(k) pathway, and the manufacturer is based in the United States.
Catalogue
Search and filter all 19 devicesFDA recalls
FDA recall records list 22 recalls initiated by Skytron, Div. the Kmw Group, Inc., the earliest on 2005-08-04 and the most recent on 2022-06-02. By recorded status: 3 ongoing and 19 terminated. The reasons filed fall into these groups: sterility or contamination, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 1
- 2020 3
- 2021 1
- 2022 1
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 2 Jun 2022 Z-1309-2022 Class II Ongoing 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.
2021
- 11 May 2021 Z-1861-2021 Class II Ongoing 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
2020
- 11 Sep 2020 Z-0071-2021 Class II Terminated 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
- 10 Mar 2020 Z-0109-2021 Class II Terminated 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.
- 5 Mar 2020 Z-1569-2020 Class II Open since 2020 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.
2019
- 18 Apr 2019 Z-1779-2019 Class II Terminated Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure
2016
- 6 Apr 2016 Z-1844-2016 Class II Terminated 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.
- 28 Mar 2016 Z-1871-2016 Class II Terminated 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.
2015
- 2 Dec 2015 Z-0655-2016 Class II Terminated 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.
Full distribution text
- 2 Dec 2015 Z-0655-2016 Class II Terminated 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.
2007
- 8 Jan 2007 Z-0524-2007 Unclassified (pre-2012) Terminated If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
Show all 22 recalls
2007
- 8 Jan 2007 Z-0525-2007 Unclassified (pre-2012) Terminated If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- 8 Jan 2007 Z-0526-2007 Unclassified (pre-2012) Terminated If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- 8 Jan 2007 Z-0527-2007 Unclassified (pre-2012) Terminated If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- 8 Jan 2007 Z-0528-2007 Unclassified (pre-2012) Terminated If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- 8 Jan 2007 Z-0529-2007 Unclassified (pre-2012) Terminated If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- 8 Jan 2007 Z-0530-2007 Unclassified (pre-2012) Terminated If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- 8 Jan 2007 Z-0531-2007 Unclassified (pre-2012) Terminated If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- 8 Jan 2007 Z-0532-2007 Unclassified (pre-2012) Terminated If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- 8 Jan 2007 Z-0533-2007 Unclassified (pre-2012) Terminated If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- 8 Jan 2007 Z-0534-2007 Unclassified (pre-2012) Terminated If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
2005
- 4 Aug 2005 Z-1496-06 Unclassified (pre-2012) Terminated 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.
- 4 Aug 2005 Z-1497-06 Unclassified (pre-2012) Terminated 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.
Frequently asked questions
How many devices does Skytron, Div. the Kmw Group, Inc. have in the registry?
The registry currently lists 19 devices for Skytron, Div. the Kmw Group, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Skytron, Div. the Kmw Group, Inc.'s devices?
Among its 19 most recently registered devices, Skytron, Div. the Kmw Group, Inc. has devices listed in FDA 510(k) (19 devices).
What risk classes do Skytron, Div. the Kmw Group, Inc.'s devices fall under?
Among its 19 most recently registered devices, the classes recorded for Skytron, Div. the Kmw Group, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Skytron, Div. the Kmw Group, Inc.?
FDA recall records list 22 recalls initiated by Skytron, Div. the Kmw Group, Inc., the most recent initiated on 2 Jun 2022. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Skytron, Div. the Kmw Group, Inc. in the registry?
The most recently registered devices listed for Skytron, Div. the Kmw Group, Inc. include STELLAR, SKYTRON ELITE 300 SURGERY TABLE, SKYTRON UNIVERSE SERIES SURGICAL LIGHTS and SKYTRON MODEL 610-2.