CLASS II Device recall · Reported 21 Oct 2020 · FDA Enforcement Report

SkyVision SDS System - Video Integration recalled

Skytron Div. The KMW Group is recalling SkyVision SDS System - Video Integration, distributed nationwide in the US. The recall was initiated on 10 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: DIPSG212460015 DIPSG212510043 DIPSG213160042 DIPSG214480117 DIPSG215040016 DIPSG219380004 DIPSG219380005 DIPSG219380006 DIPSG219380007 DIPSG219380008 DIPSG219380013 DIPSG219380014 DIPSG219380015 DIPSG219380016 DIPSG219380017 DIPSG219380018 DIPSG219380019 DIPSG219380020 DIPSG219380021 DIPSG219380022 DIPSG219380023 DIPSG219380024 DIPSG219380025 DIPSG219380026 DIPSG219420002 DIPSG219420003 DIPSG219420004 DIPSG219420005 DIPSG219420006 DIPSG219420007 DIPSG219470004 DIPSG219470008 DIPSG219470011 DIPSG219470013 DIPSG219470014 DIPSG219490014

Quantity recalled36 units

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-0109-2021
FDA event ID: 86439
Recalling firm: Skytron Div. The KMW Group, Grand Rapids, MI
Classification: Class II
Status: Terminated
Recall initiated: 10 Mar 2020
FDA classified: 15 Oct 2020
Reported: 21 Oct 2020
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

10 Mar 2020	Recall initiated by company
15 Oct 2020	Classified by FDA	+219 days
21 Oct 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

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

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.

Where it was distributed

US Nationwide distribution including in the states of CA, FL, IA, MI, MN, NY, PA, TX, WA.

Nationwide California Florida Iowa Michigan Minnesota New York Pennsylvania Texas Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Numbers: DIPSG212460015 DIPSG212510043 DIPSG213160042 DIPSG214480117 DIPSG215040016 DIPSG219380004 DIPSG219380005 DIPSG219380006 DIPSG219380007 DIPSG219380008 DIPSG219380013 DIPSG219380014 DIPSG219380015 DIPSG219380016 DIPSG219380017 DIPSG219380018 DIPSG219380019 DIPSG219380020 DIPSG219380021 DIPSG219380022 DIPSG219380023 DIPSG219380024 DIPSG219380025 DIPSG219380026 DIPSG219420002 DIPSG219420003 DIPSG219420004 DIPSG219420005 DIPSG219420006 DIPSG219420007 DIPSG219470004 DIPSG219470008 DIPSG219470011 DIPSG219470013 DIPSG219470014 DIPSG219490014

Where was it sold?

US Nationwide distribution including in the states of CA, FL, IA, MI, MN, NY, PA, TX, WA.

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
6 Jul 2022Device	CLASS II	GCX Channel Mounting Accessory recalled by Skytron, Div. The KMW Group	Skytron Div. The KMW Group	Other	Nationwide
23 Jun 2021Device	CLASS II	Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 recalled	Skytron Div. The KMW Group	Device Malfunction	Nationwide
14 Oct 2020Device	CLASS II	Vgdf-sky (R4-010-06) Vga TO Fiber Converter-Single Format recalled	Skytron Div. The KMW Group	Device Malfunction	5 states
1 Apr 2020Device	CLASS II	Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen recalled	Skytron Div. The KMW Group	Device Malfunction	10 states
19 Jun 2019Device	CLASS II	Skytron Integrity 270 Steam Sterilizer recalled	Skytron Div. The KMW Group	Device Malfunction	Nationwide

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