FDA Medical Device Recalls (openFDA)
Philips Medical Systems, Inc.: Easy Diagnost Eleva Universal Fluoroscopic applications
- Recall number
- Z-0431-2014
- Recalling firm
- Philips Medical Systems, Inc.
- Product
- Easy Diagnost Eleva Universal Fluoroscopic applications
- Status
- Terminated
- Initiated
- 2013-10-30
- Posted
- 2013-12-02
- Terminated
- 2017-01-09
- Reason
- The delivered application software was an outdated version to the model of equipment.
- Root cause
- Software design
- Action
- 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 Cusromers were informed that the delivered application software was an outdated version to the model of their expipment and that a Philips Field Engineer will be implementing an upgrade of the application software.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.
- Quantity
- 19 devices
- Distribution
- Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC.
- Lot, serial or model codes
- 706050, 706083, 706088
- 510(k) numbers
- ["K031535"]
- PMA numbers
- not on file
- Product code
- KPR
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28