Philips Healthcare Ingenuity Core Computed Tomography X-ray system
Recall
- Recall Number
- Z-0406-2016
- Event Number
- 71926
- Firm
- Philips Electronics North America Corporation
- FEI Number
- 1218950
- Product Code
- JAK
- Status
- Terminated
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- April 14, 2015
- Terminated
- September 23, 2020
- Address
- 3000 Minuteman Rd, Andover, MA, 01810-1032
Description
Philips Healthcare Ingenuity Core Computed Tomography X-ray system
During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.
Philips Healthcare Planned Action: 1. Philips Healthcare will contact customers and initiate a software update to correct the defect. 2. Philips Healthcare engineers will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that Philips Healthcare will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Philips Healthcare will implement this CAP by April 1, 2016. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office.
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Mayanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Republic of Korea, Reunion, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Tanzania, Tunisia, Turkey, United Arab Emirates, Uzbekstan and Vietnam.
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