Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System
This recall has been terminated (originally issued September 6, 2015).
- Company
- Philips Healthcare
- Recall Initiated
- September 6, 2015
- Terminated
- March 4, 2021
- Recall Number
- Z-1719-2016
- Quantity
- US - 423
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
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
Distribution
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.
Lot / Code Info
Software v. 4.13, 4.14 and 4.15.
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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