Z-0109-2021Class II

SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 -

Name: Z-0109-2021 SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 -
Creator: Skytron, Div. The KMW Group, Inc
Published: 2020-03-10
License: https://open.fda.gov/license/

Skytron, LLC / initiated 2020-03-10 / Terminated / root cause: software

FDA source

Skytron, Div. The KMW Group, Inc began a recall of 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... on 2020-03-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0109-2021
Classification: Class II
Status: Terminated
Initiated: 2020-03-10
Posted: 2020-10-15
Terminated: 2021-06-01
Recalling firm: Skytron, LLC
Product: 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.
Product code: LMD System, Digital Image Communications, Radiological
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.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: Skytron Authorized Representatives contacted the affected facilities beginning on 3/4/20 via phone or in person .Skytron Authorized Representatives visited sites to correct the issue wih the following message: Skytron, LLC is voluntarily recalling a limited number of SDS integration units. The SDS router may experience an intermittent issue related to display output functionality. This failure poses a potential safety risk to patients. This firmware update is being conducted to correct the failure.
Quantity in commerce: 36 units
Distribution: US Nationwide distribution including in the states of CA, FL, IA, MI, MN, NY, PA, TX, WA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0109-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0109-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-21	2020-10-15

Product code LMD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)