allura xper systems - allura xper fd10 , allura xper fd10/10 , allura xper fd20, allura xper fd20/10, allura xper fd20/20 and allura cv20 의 안전성 경고

Safety alert

2011-08-04

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20110804a.html

Field safety notice: philips allura xper systems - allura xper fd10 (f/c), allura xper fd10/10 (incl. or table), allura xper fd20, allura xper fd20/10, allura xper fd20/20 and allura cv20 philips healthcare has issued a field safety notice to the customers of allura xper systems. investigation of field problems on the allura xper systems showed that there is a problem related to the harddisk firmware. the hard disk drive itself is working fine but the used firmware suffers from an incorrect incrementing smart counter. this might result in a very high “raw read error” count which will lead in a so called “smart trip” and subsequently will take the hard disk drive offline. consequently the system might intermittently freeze. this can vary from several seconds up to one minute. if during a procedure the system intermittently freezes for several seconds and up to one minute, the system does not generate x-ray anymore and no geometry movement is possible during this period of time. if this happens during a critical phase in a procedure this might lead to a disturbance in the procedure and a possible injury to the patient. this intermittent image freeze / system freeze is not foreseeable or recognizable by the user. the manufacturer recommended customers not to reboot or take any other actions until the system proceeds on its own, because this could slowdown the systems automatically recovery. the manufacturer will provide users a cd with the correct firmware and an installation procedure to implement the corrective actions. according to the local supplier, hong kong is affected. the local supplier is following up the issue with its customers. if you are in possession of the affected product, please contact your supplier (hotline: 2821-5473) for necessary actions.