SkyVision SDS System — Class II medical device recall Z-0109-2021
Terminated recall by Skytron, Div. The KMW Group, Inc, reported 2020-10-21, distributed nationwide. Intermittent failure of a signal being sent to a monitor from the touch panel display causing the displaying m
| Recall number | Z-0109-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Skytron, Div. The KMW Group, Inc, Grand Rapids, MI, United States |
| Recall initiated | 2020-03-10 |
| Classified | 2020-10-15 |
| Reported by FDA | 2020-10-21 |
| Terminated | 2021-06-01 |
| Distributed | Nationwide (US) |
| Quantity | 36 units |
| 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 and 11 more |
| Model numbers | GC-SDS-BSCB-200 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0109-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.