Philips Brilliance iCTCT Systems with software version 4.1.6 의 리콜

Recall

RC-2017-RN-01070-1

Class II

2017-08-16

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01070-1

Philips have identified the following issues with brilliance ict s/w v4.1.61. scan parameters exceeds system resources2. scan may start at the top of the head, which may not be where the operator is expecting the scan to start3. error message appears “the exam application stopped working” & will instruct the operator to close the program4. during a bolus tracking procedure, after acquiring the surview, locator & tracker, the scanner may move into place, give patient breathing instructions, & then fail to acquire the scan5. image volumes are not found in patient directory when thin images are included in one of the multiple results6. application may fail when modifying the results plan box during 3d calcium score7. tube too hot8. memory overflow9. while the reconstruction is in progress disconnecting the recon box (cirs) may not give error message10. in the plan viewer, if the start position is modified the total length of the acquisition will change as well.

Philips Healthcare is notifying the affected users of these issues via this Customer Information Letter. The customers will be contacted by their local Field Service Engineer for implementation of the field correction under FC072800678 to be conducted free of charge to the customer.