Recall Z-1829-2012 ยท IZI System, X-Ray, Angiographic
Philips Healthcare Inc.
Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cable Product Codes: 708034, 708037 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/ universal system. General R/F, performed along with more specialized interventional applications. This includes the following general areas: Digest
| Date | Jun 20, 2012 (initiated May 21, 2012) |
| Status | Terminated |
| Reason | MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement |
| Root cause | Device Design |
| Action | Philips Healthcare Imaging issued Urgent Field Safety Notice dated May 21, 2012, to accounts informing an inspection will be performed of the unit. The Cable guiding plate will be replaced. If the cables show any damage the complete cable set wll also be replaced. No action is be taken by the customer. For further information customers should call 1-800-722-9377. For questions regarding this recall call 978-687-1501. |
| Quantity | 433 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of: Nationwide Foreign: Australia Austria Belgium Bharain Canada China Columbia Czech Republic Denmark Dutch Antilles Egypt Estonia Finland France Germany Hong Kong Ireland Israel Italy Latvia Lebanon Luxembourg Malaysia Mexico Netherlands |
| FDA record | Open on fda.gov |