Philips Multi Diagnost Eleva with FlatDetector
This recall has been terminated (originally issued February 26, 2015).
- Company
- Philips Medical Systems, Inc.
- Recall Initiated
- October 14, 2013
- Posted
- February 26, 2015
- Terminated
- January 23, 2017
- Recall Number
- Z-1045-2015
- Quantity
- 238
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.
Distribution
Worldwide Distribution - USA ( nationwide ) to the states of : AR, AZ, CA, CO, DE, FL, GA, HI, IL, IA, KY, KS, LA, MI, MO, MS, NC, NY, OH, PA, TN, TX, VA, VT, WA, WY and WV., and the countries of Austria, Australia, Colombia, Germany, Switzerland, Turkey, Ireland, Dubia and United Kingdom.
Lot / Code Info
Product Code: 708037
Root Cause
Radiation Control for Health and Safety Act
Action Taken
Philips Healthcare Planned Action: 1. Software updates to SW R6.1.3 through Field Change Orders (FCOs) FCO70800140 and FCO70800142. 2. A customer notification letter which includes a statement that Philips Healthcare will without charge, remedy the defect or bring the product into compliance. 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 September 1, 2015. For further questions please call (978) 687-1501.