NA FD77900Recalls & reported problems
Corporation Steris Canada · The MIS Rack SS for Vision Washer Disinfectors is multi-functional and has been designed to process instrument trays, cannulated suction tips, general purpose Racks and miscellaneous small items during processing. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995151218), received between Jul 12, 2023 and Jul 12, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT WHILE AN EMPLOYEE WAS UNLOADING THE THREE-LEVEL MANIFOLD RACK FROM THEIR WASHER/DISINFECTOR, THE FLEXIBLE HOSE DISCONNECTED, AND HOT WATER RAN OUT OF THE HOSE AND CONTACTED THE EMPLOYEE'S ANKLE SUBSEQUENTLY CAUSING A BURN. THE EMPLOYEE SOUGHT AND RECEIVED MEDICAL TREATMENT (BANDAGE).
Patient problems: Burn(s)
MAUDE report 17309206 ↗
Other Disinfector, medical devices devices
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- GETINGE CM320-SERIESGetinge Disinfection AB · Disinfector, Medical Devices2 recalls3 reports
- GETINGE CM320-SERIESGetinge Disinfection AB · Disinfector, Medical Devices2 recalls1 report
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- Getinge Aquadis 56 56MGetinge Disinfection AB · Disinfector, Medical Devices1 recall11 reports
- AMSCO 7052HPCorporation Steris Canada · Disinfector, medical devices1 recall10 reports
- GETINGE 9100-SERIES 9128EGetinge Disinfection AB · Disinfector, Medical Devices1 recall10 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.