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System 83 Revolve

Wassenburg Medical, Inc. · Model System 83 Revolve · UDI-DI 00860010835241

FEB
10
510(k) clearances
5,104
Adverse events (22 deaths)
43
Recalls
23
Facilities

Description

The System 83 Revolve® Endoscope Washer/Disinfector is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes utilizing a detergent and FDA cleared high-level disinfectant validated by Wassenburg Medical. The System 83 Revolve® utilizes a processing chamber and the immersion method to perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high-level disinfected endoscope. The System 83 Revolve® is capable of automated detergent dispensing and transfer of disinfectant solution between the reservoir and processing chamber. Following disinfection, the endoscopes and channels are automatically rinsed with potable water that is filtered through a water filtration system that contains a 0.1 micron bacteria filter and the channels are then flushed with air. A semi-automated air/alcohol flush must be completed at the end of the cycle. At completion, the operator prints out the endoscope reprocess

Recalls

DateFirmReason
2026-09-21Steris CorporationIf the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from
2026-09-21Steris CorporationIf the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from
2026-09-21Steris CorporationIf the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25Olympus Corporation of the AmericasXXX
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.