SFDA National Center for Medical Devices Reporting

X

Your changes have been successfully saved

Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Home Published FSNs/Recalls About NCMDR Contact Us FAQ Login

NCMDR Recall

Back

Reference Number:	mdprc 049 10 17 000
Date submitted:	10/12/2017

Manufacturer:	Philips Healthcare
Device Type:	Brilliance 64, Ingenuity Core, Ingenuity Core 128, Ingenuity CT
Description:	Computed Tomography
Medical Device Identifier:	Brilliance 64 728231 Ingenuity Core 728321 Ingenuity 1C2or8e 728323 Ingenuity CT 728326 : Running software version: 4.1,6 The products affected will display one of the following software versions: V4.1 .6.XXOSO V4.1 .6.XX032
Reason of Field Safety Corrective Action:	Issue 1: Cardiac Signal not found in Workflow Issue If the operator loads a Cardiac Exam Card, the cardiac signal is shown during cardiac scan but not shown during the surview. Issue 2: Scan may start at the top of the head, which may not be where the operator is expecting the scan to start If the operator plans to do multiple scans with multiple results including identical links then the first result of the subsequent acquisition will follow the last result of previous acquisition and not the identical link of the previous acquisition. The possible outcome is that the results of the second scan could be planned outside the boundaries of the expected results. Issue 3: Pulmo Gates on Cardiac Workflow Issue If the operator loads a Cardiac Exam Card after performing a Pulmonary scan, the Pulmo wave may be present. ‘ Issue 4: In the Plan viewer if the start position is modified the total length of the acquisition will changes as well. In the Plan viewer if the start position is modified by the length of one slice thickness, then the total length of the acquisition may change by the same length value as well. Note this occurs only when planning without a surview. Issue 5: Image volumes are not found in patient directory when thin images are included in one of the multiple results The operator completes a CT Orbit procedure and clicks End Study’. The final thin images may not appear in Patient Directory. When the operator clicks ‘Recon’ to attempt to do an off-line recon the ‘View 2 application may fail. Issue 6: Application may fail when modifying the results Plan Box during 3D Calcium Score While setting up a 3D Calcium Score scan, if the Operator attempts to modify the plan box of a result on the surview, the application may fail and require a restart. Issue 7; Tube too hot The Operator presses Go’ to execute a timed scan sequence and the following message may display: “Tube Too Hot”. Issue 8: Memory overflow Issue When performing a CT clinical procedure, it is possible that the scan may be aborted as a result of a memory overflow issue. Issue 9: While the reconstruction is in progress disconnecting the Recon box (CIRS) may not give error message When the connection between Host computer and recon box (CIRS) is disrupted during reconstruction, the operator may not be informed and may require that the operator reconstruct the images through Off-line reconstruction. Issue 10: Issue with the GeneratorMonitor state machine in RHost code Issue When the operator turns the key switch on the CT box to Off and turns it back on before the system gantry is turned off completely the system might make the generator to go into a configuration state and ceases to monitor and to send the updated real time data for the tube’s kV and mA.
Remedy Action:	Issue 1: Cardiac Signal not found in Workflow Issue Operator can reset the Gantry by doing a full shutdown. Issue 2: Scan may start at the top of the head, which may not be where the operator is expecting the plan to be. Operator can verify the plan box of each result before scanning. Issue 3: Pulmo Gates on Cardiac Workflow Issue Operator can restart the console between the Pulmo and the Cardiac exams Issue 4: In the Plan viewer if the start position is modified the total length of the acquisition will changes as well. If the start position is modified in the plan viewer, then adjust the total length of the acquisition as desired. Issue 5: Image volumes are not found in patient directory when thin images are included in one of the multiple results If Raw Data is available after application restart, then the operator can do off line reconstruction to create desire results. Issue 6: Application may fail when modifying the results Plan Box during 3D Calcium Score While planning 3D calcium Score procedure, plan the last result in the series list first. Issue 7: Tube too hot Operator can lower the DRI(DoseRight Index). Issue 8: Memory overflow None Issue 9: While the reconstruction is in progress disconnecting the Recon box (CIRS) may not give error message Issue. If the images do not reconstruct as expected restart the recon box (CIRS) and host computer, then reconstruct the images using off-line recon. Issue 10: Issue with the GeneratorMonitor state machine in RHost code Issue If the operator turns the key switch on the CT box to off, wait till gantry is fully shutdown prior to turning the key back on
Athorized Representative/Importer/Distributor:	Philips Healthcare Saudi Arabia Ltd.
Report Source:	NCMDR
Source Ref. Number:	A82A86013B194
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Philips Healthcare.pdf

View History