Easy Diagnost Eleva Universal Fluoroscopic applications
FDA device recall Z-0431-2014 · posted 2013-12-02 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc.
- Reason for recall
- The delivered application software was an outdated version to the model of equipment.
- Action taken
- Philips Medical Systems sent an Urgent - Field Safety Notice dated October 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Cusromers were informed that the delivered application software was an outdated version to the model of their expipment and that a Philips Field Engineer will be implementing an upgrade of the application software. Customers were instructed to review the information contained in the letter with all memebers of their staff who need to be aware of its contents. Customers with questions were instructed to contact their Philips representataive: Technical Support Line 1-800-722-9377. For questions regarding this recall call 1-800-722-9377.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 19 devices
- Distribution
- Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC.
- Date initiated
- 2013-10-30
- Date posted
- 2013-12-02
- Date terminated
- 2017-01-09
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS EASYDIAGNOST ELEVA (K031535) | Philips Medical Systems North America Co. | 2003-06-17 |