Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector w
FDA device recall Z-1829-2012 · posted 2012-06-20 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 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
- Date initiated
- 2012-05-21
- Date posted
- 2012-06-20
- Date terminated
- 2017-01-18
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MULTIDIAGNOST ELEVA (K050151) | Philips Medical Systems North America, Inc. | 2005-02-09 |
| PHILIPS MULTIDIAGNOST ELEVA (K023441) | Philips Medical Systems | 2002-10-30 |