Recall Z-1212-2012 ยท IZI System, X-Ray, Angiographic
Philips Healthcare Inc.
Philips Healthcare MD Eleva system. Multi-functional fluoroscopy, radiography and angiography systems that can perform more specialized interventional applications
| Date | Mar 29, 2012 (initiated Nov 19, 2011) |
| Status | Terminated |
| Reason | It was discovered there was a software error where the air karma rate is not displayed correctly on the user interface. |
| Root cause | Software design |
| Action | 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) 787-150 |
| Quantity | 92 ( 24 Eleva 11s, and 68 Eleva FDs ) |
| Distribution | Worldwide Distribution - USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.