Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
FDA device recall Z-2156-2012 · posted 2012-08-08 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired.
- Action taken
- Philips issued an Urgent Field Safety Notice dated July 2, 2012 to all affected customers. The letter identified the affected product, problem description, actions to be taken by the customer/user in order to prevent risks for patients or users and actions planned by Philips to correct the problem. For question or support concerning this issue contact your local Philips representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 41 units
- Distribution
- Worldwide Distribution - US (nationwide) including the states of CA, CT, MI, MN, MN, NC, NY, NY, VA and the countries of Belgium, Columbia, Czech Republic and Denmark. France Germany Italy Latvia Luxe
- Date initiated
- 2012-07-11
- Date posted
- 2012-08-08
- Date terminated
- 2013-03-26
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MULTIDIAGNOST ELEVA (K050151) | Philips Medical Systems North America, Inc. | 2005-02-09 |