Philips Healthcare MD Eleva system. Multi-functional fluoroscopy, radiography and angiography systems that can perform more specialized interventional applications
This recall has been terminated (originally issued March 29, 2012).
- Company
- Philips Healthcare Inc.
- Recall Initiated
- November 19, 2011
- Posted
- March 29, 2012
- Terminated
- August 26, 2020
- Recall Number
- Z-1212-2012
- Quantity
- 92 ( 24 Eleva 11s, and 68 Eleva FDs )
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
It was discovered there was a software error where the air karma rate is not displayed correctly on the user interface.
Distribution
Worldwide Distribution - USA (nationwide)
Lot / Code Info
MultiDiagnost Eleva II - 708036, 708032, MultiDiagnost Eleva FD - 708037, 708034,
Root Cause
Software design
Action Taken
A field correction action will be undertaken to correct the software error in affected systems worldwide. Your proposed action to bring the product into compliance with regulatory requirements is to institute a worldwide field correction to replace the software error in affected systems by updating the current software to version R6.1.2. The timeframe for completion of this field action will be 6 months post field action publication. Preventive actions: The software has been corrected moving forward in subsequent releases for these products. For further questions please call (978) 787-1501.