MDZClass II
Cleaners, Medical Devices
General Hospital · 21 CFR 880.6992
MDR events12All time
Recalls2All time
Registered firms2Currently listed
510(k) clearances2All time
Recent MDR events
12 adverse event reports on file
- GETINGE 46-SERIESSep 13, 2013MalfunctionGetinge Disinfection Ab9616031-2013-00004
- GETINGE 46-SERIESAug 22, 2013MalfunctionGetinge Disinfection Ab9616031-2013-00003
- GETINGE 46-SERIESJul 17, 2013MalfunctionGetinge Disinfection Ab9616031-2013-00002
- GETINGE 46-SERIESMay 15, 2013MalfunctionGetinge Disinfection Ab9616031-2013-00001
- CITRIZYMEMar 8, 2012OtherPascal Co., Inc.3011632-2011-00001
- GETINGEOct 2, 2009MalfunctionGetinge Disinfection Ab9616031-2009-00001
- GETINGEMar 12, 2004Getinge Disinfection Ab9616031-2004-00001
- AQUA FRESH-AQUA BLASTDec 16, 2003Glaxo Smith KlineMW4003660
- SYNVISCMay 21, 2002InjuryGenzyme Biosurgery/alex Kuta-genzyme Biosurgery2246315-2002-00013
- GETINGEMar 22, 2001MalfunctionGetinge Disinfection Ab9616031-2001-00001
Event type breakdown
Malfunction7
Unspecified3
Injury1
Other1
Recalls
2 recall events for this product code
- Steris CorporationTerminatedApr 30, 2015
Caviwave Pro Ultrasonic Cleaning System,
Should the Caviwave Pro Ultrasonic Cleaning System experience a temporary interruption in electrical power during a processing cycle, the circulation pump may stop functioning. In addition, it is possible that the ultrasonic generator may stop working. The machine does not provide an alert notifying the user of this device malfunction.
Z-1559-2015 · View FDA record ↗ - Ultracell Medical TechnologiesTerminatedJan 30, 2003
Ultacell Diamond Knife Cleaning Block 15mm
Sterility of the device is compromised
Z-0484-03 · View FDA record ↗
Registered firms
2 firms currently registered for this product code
510(k) clearances
2 clearances for this product code