Philips Healthcare MD Eleva system. Multi-functional fluoroscopy, radiography and angiography systems that can perform m
FDA device recall Z-1212-2012 · posted 2012-03-29 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- It was discovered there was a software error where the air karma rate is not displayed correctly on the user interface.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 92 ( 24 Eleva 11s, and 68 Eleva FDs )
- Distribution
- Worldwide Distribution - USA (nationwide)
- Date initiated
- 2011-11-19
- Date posted
- 2012-03-29
- Date terminated
- 2020-08-26
- Location
- Andover, MA
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