FDA Device recall Z-1008-2026
BVI Leos Laser and Endoscopy System
- FDA Device
- Class II
- ongoing
- Published 2026-01-07
On 2026-01-07 the FDA classified a Class II recall of BVI Leos Laser and Endoscopy System by Beaver Visitec International, citing manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. T….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1008-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-05 |
| Published | 2026-01-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beaver Visitec International |
| Distribution | US |
Product
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Reason
Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).
Identifiers
| code_info | Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Beaver Visitec International
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001417
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000775
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001568
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001020
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000828
FDA Device · Class II · 2024-09-04 · Beaver Visitec International
All Beaver Visitec International recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1008-2026%22
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