Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary
FDA device recall Z-0584-2014 · posted 2013-12-27 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc.
- Reason for recall
- X-ray system C-arm casting may loosen and fall
- Action taken
- Philips Medical Systems issued a Urgent Field Safety Notice-Warning Label and Inspection, dated November 21, 2013, advising of potential of C-arm detaching and requesting a daily inspection and a safety warning label . If you need any further information or support concerning this issue, please contact your local Philips representative. 1-800-722-9377.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 424 units
- Distribution
- Worldwide Distribution - USA (Nationwide) including Puerto Rico and the countries of : Afghanistan, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Egypt, Franc
- Date initiated
- 2013-12-05
- Date posted
- 2013-12-27
- Date terminated
- 2017-01-17
- 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 |
|---|---|---|
| PHILIPS ESSENTA DR (K070528) | Philips Medical Systems GmbH, Dmc | 2007-03-09 |