FDA Medical Device Recalls (openFDA)
Philips Healthcare Inc.: Philips Healthcare MD Eleva system. Multi-functional fluoroscopy, radiography and angiography systems that can perform more specialized interventional applications
- Recall number
- Z-1212-2012
- Recalling firm
- Philips Healthcare Inc.
- Product
- Philips Healthcare MD Eleva system. Multi-functional fluoroscopy, radiography and angiography systems that can perform more specialized interventional applications
- Status
- Terminated
- Initiated
- 2011-11-19
- Posted
- 2012-03-29
- Terminated
- 2020-08-26
- Reason
- It was discovered there was a software error where the air karma rate is not displayed correctly on the user interface.
- 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
- 92 ( 24 Eleva 11s, and 68 Eleva FDs )
- Distribution
- Worldwide Distribution - USA (nationwide)
- Lot, serial or model codes
- MultiDiagnost Eleva II - 708036, 708032, MultiDiagnost Eleva FD - 708037, 708034,
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IZI
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28