Z-0017-2018 Class II Terminated
FDA device recall Z-0017-2018 was initiated by Philips Electronics North America Corporation on January 18, 2017 and is designated Class II. Reason for recall: During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculat… The recall status is terminated (terminated February 26, 2020). Affected quantity: US - 606.
Recall Details
- Product Type
- Devices
- Report Date
- October 25, 2017
- Initiation Date
- January 18, 2017
- Termination Date
- February 26, 2020
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- US - 606
Product Description
Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Reason for Recall
During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient.
Distribution Pattern
USA (nationwide) Distribution
Code Information
Software version 4.16