—#115393

Product

Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K031535
Affected lot / code info: Serial Numbers 362600, 362601, 364209, 364210, 375245, 375850, 376439, 384396, 387492, 398185, 399440, 399621, 399623, 402409

Why it was recalled

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 (FDA determination)

Software design (manufacturing process)

Action the firm took

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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: US Nationwide Distribution including the states of FL, CA, WA, AZ, NC, KY, DE, AZ and MO.

Timeline

Recall initiated: 2013-01-16
Posted by FDA: 2013-02-01
Terminated: 2017-01-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115393. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.