Z-2154-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2017
- Initiation Date
- May 11, 2017
- Termination Date
- July 10, 2018
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- US - 132
Product Description
Philips DigitalDiagnost 3.1.x X-Ray System
Reason for Recall
During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions.
Distribution Pattern
USA(nationwide) Distribution to the states of : AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, ND, NE, NH, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA and WI
Code Information
DigitalDiagnost Upgrade Release 3.1.x to 3.1.3