—#107118

Product

Philips Healthcare MD Eleva system. Multi-functional fluoroscopy, radiography and angiography systems that can perform more specialized interventional applications

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: MultiDiagnost Eleva II - 708036, 708032, MultiDiagnost Eleva FD - 708037, 708034,

Why it was recalled

It was discovered there was a software error where the air karma rate is not displayed correctly on the user interface.

Root cause (FDA determination)

Software design

Action the firm took

A field correction action will be undertaken to correct the software error in affected systems worldwide. Your proposed action to bring the product into compliance with regulatory requirements is to institute a worldwide field correction to replace the software error in affected systems by updating the current software to version R6.1.2. The timeframe for completion of this field action will be 6 months post field action publication. Preventive actions: The software has been corrected moving forward in subsequent releases for these products. For further questions please call (978) 787-1501.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide)

Timeline

Recall initiated: 2011-11-19
Posted by FDA: 2012-03-29
Terminated: 2020-08-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107118. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.