Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System
FDA Recall Z-1719-2016 · Posted None
Recalling FirmPhilips Healthcare
Recall StatusTerminated
Product CodeJAK
Date Initiated2015-09-06
Date Terminated2021-03-04
Product QuantityUS - 423
Reason for Recall
Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm
Firm Action
Philips plans to initiate a field corrective action that will install a new software release to address the issue. Philips will modify the systems in the field to correct the defect at no cost to the customer.
1. You will contact customers and initiate a software update to correct the defect.
2. You will install the software and perform testing to ensure the software update was effective.
3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance.
For further questions, please call (1-800) 722-9377, Option 5
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY, NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.