Statim 7000 Cassette Sterilizer (2015-01-16) — recall 52669

Reported risk: This recall has been initiated due to a part that is no longer available. This part is an RFID (radio-frequency identification) tag which is used in the chamber seal to monitor the number of cycles ran in order to inform the user when it is necessary to change the chamber seal. Our current supplier of this part has decided to exit the RFID tag business and a suitable replacement was not found. Therefore, all future cassette seals will no longer contain the RFID tag (seals are regularly replaced by the user). When this tag is not present, the machine will not allow a cycle to start with the current software. LN order to implement this change in the Statim 7000 and remove the RFID tag from the cassette seal, the RFID board software must be updated to allow the unit to run without an RFID tag in the cassette seal. This will be performed by trained technicians at the user site. There is no need for the unit to be returned to the manufacturer for this software update. The life of the seal is still 1000 cycles or every twelve months, whichever comes first, but no notification will be given on the unit once the tag is no longer present and the software has been updated. It will be the user's responsibility to monitor the number of cycles ran and the seal's performance. Manual monitoring of seal replacement is a common practice for most steam sterilizers on the market.