Z-1212-2012

Philips Healthcare MD Eleva system. Multi-functional fluoroscopy, radiography and angiography systems that...

Name: Z-1212-2012 Philips Healthcare MD Eleva system. Multi-functional fluoroscopy, radiography and angiography systems that...
Creator: Philips Healthcare Inc.
Published: 2011-11-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-11-19 / Terminated / root cause: software

FDA source

Philips Healthcare Inc. began a recall of Philips Healthcare MD Eleva system. Multi-functional fluoroscopy, radiography and angiography systems that can perform more specialized interventional... on 2011-11-19. The reason FDA records is "It was discovered there was a software error where the air karma rate is not displayed correctly on the user interface". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1212-2012
Status: Terminated
Initiated: 2011-11-19
Posted: 2012-03-29
Terminated: 2020-08-26
Recalling firm: Philips North America LLC
Product: Philips Healthcare MD Eleva system. Multi-functional fluoroscopy, radiography and angiography systems that can perform more specialized interventional applications
Product code: IZI System, X-Ray, Angiographic
Reason for recall: It was discovered there was a software error where the air karma rate is not displayed correctly on the user interface.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 92 ( 24 Eleva 11s, and 68 Eleva FDs )
Distribution: Worldwide Distribution - USA (nationwide)
Product codes and lots: MultiDiagnost Eleva II - 708036, 708032, MultiDiagnost Eleva FD - 708037, 708034,

Product code IZI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)