Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
This recall has been terminated (originally issued February 1, 2013).
- Company
- Philips Healthcare Inc.
- Recall Initiated
- January 16, 2013
- Posted
- February 1, 2013
- Terminated
- January 23, 2017
- Recall Number
- Z-0767-2013
- Quantity
- 14 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide Distribution including the states of FL, CA, WA, AZ, NC, KY, DE, AZ and MO.
Lot / Code Info
Serial Numbers 362600, 362601, 364209, 364210, 375245, 375850, 376439, 384396, 387492, 398185, 399440, 399621, 399623, 402409
Root Cause
Software design (manufacturing process)
Action Taken
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.