—#109279

Product

Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system

FDA product code: IXR — Table, Radiographic, Tilting
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K031535, K970640
Affected lot / code info: All systems with Eleva software version 4.x and stitching option.

Why it was recalled

If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. If, additionally, the measurement tool is not used to check the ruler, or is used in the right way (ie: calibration), such calibration error is not detected. As a result of this, a surgical intervention may be execut

Root cause (FDA determination)

Device Design

Action the firm took

Philips sent an Urgent - Field Safety Notice letter dated May 11, 2012 to their affected customers. The letter identified the affected product, what the issues are, under what circumstances they may occur and the actions to be taken to avoid or minimize the occurrence of the issue Philips plans to supply an Addendum to the Instruction for Use. A Philips Service Engineer will contact the affected customers as soon as the Field Action Kit is ready to be implemented. For questions contact your local Philips representative: Technical Support Line 1-800-722-9377.

Recalling firm

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

Distribution

Distribution pattern: 6 US customers

Timeline

Recall initiated: 2012-05-11
Posted by FDA: 2012-06-18
Terminated: 2016-10-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #109279. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.