FDA Medical Device Recalls (openFDA)
Philips Healthcare Inc.: Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
- Recall number
- Z-0767-2013
- Recalling firm
- Philips Healthcare Inc.
- Product
- Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
- Status
- Terminated
- Initiated
- 2013-01-16
- Posted
- 2013-02-01
- Terminated
- 2017-01-23
- Reason
- The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.
- Root cause
- Software design (manufacturing process)
- Action
- Phillips issued an Urgent Field Safety Notice to all customers on January 14, 2013, to notify users that the Phillips EasyDiagnost Eleva systems, release 3.0 has a mirror icon that could be misinterpereted and could potentially lead to misdiagnosis. Philips will upgrade the system to version 3.1 which involves software and hardware upgrades of the system. This software provides a replacement icon that reduces the risk of the potential misinterpretation of the original mirror icon. Additionally, Philips will provide updated Instructions for Use (IFU) for the Eleva workspot and the EasyDiagnost 3.1 system and an addendum to the EasyDiagnost system IFU. Users will be contacted by Phillips to schedule the installation. For questions contact your local Philips representative: 1-800-722-9377.
- Quantity
- 14 units
- Distribution
- US Nationwide Distribution including the states of FL, CA, WA, AZ, NC, KY, DE, AZ and MO.
- Lot, serial or model codes
- Serial Numbers 362600, 362601, 364209, 364210, 375245, 375850, 376439, 384396, 387492, 398185, 399440, 399621, 399623, 402409
- 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