Philips Healthcare DuraDiagnost stationary X-ray system
This recall has been terminated (originally issued June 3, 2016).
- Company
- Philips Healthcare
- Recall Initiated
- November 10, 2015
- Posted
- June 3, 2016
- Terminated
- May 3, 2017
- Recall Number
- Z-1696-2016
- Quantity
- 5
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.
Distribution
USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.
Lot / Code Info
software version - 4.0.2, 4.0.3, 4.0.4 into 4.0.5
Root Cause
Radiation Control for Health and Safety Act
Action Taken
Philips Healthcare plans to correct the defect at no cost to customers by implementing a field correction involving the installation of new software. 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.