Retiro De Equipo (Recall) de Device Recall Ingenuity TF

Recall

79008

Class 2

Z-0562-2018

2017-12-11

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161075

A software issue causes pet reconstructions to fail intermittently. it was determined that reconstructions fail due to a negative table position (-1 value is inserted) in the raw data list file, rather than the actual table position. this error has been found to occur in two scenarios: 1) when the system operator cancels an acquisition a. the error will occur every time a scan is cancelled by the operator. 2) couch position requests within the software sequence were delayed a. the error occurs intermittently, but has been found to occur more frequently when the gantry s network is heavily loaded with multiple retrospective reconstructions running in parallel. b. the error manifests to the technologist by an error message and failed status on the reconstruction monitor and the error message result {0} failed to reconstruct" on the acquisition workflow window during reconstruction after the patient scan has been completed. in both scenarios, the acquisition data will not be able to be reconstructed and will therefore be unusable.

Philips Healthcare sent an Urgent-Field Safety Notice dated December 11, 2017. U.S. Customers will be receive the letter via USPS Certified mail. Non-U.S.. customers will receive the letter through Philips Global Markets following local regulations. Philips is informing customers of the software issues on the systems, as well as available workarounds to prevent these issues from occurring or to minimize their impact. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts)