Philips Azurion 7 M20 XperGuide Software Recall for Incorrect Overlay Display
Philips is recalling Azurion 7 M20 systems with XperGuide software because a software defect may display incorrect needle paths if the L-arm is mispositioned.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria for potential incorrect medical guidance.
Plain-English summary
Philips North America, LLC is recalling the Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system. The recall involves 25 units, including 6 in the United States and 19 outside the US. The affected systems are interventional fluoroscopic x-ray systems with system code 722079.
The recall is due to a software defect where the system does not prevent the use of live guidance if the L-arm stand is not repositioned to the initial XperCT scan position. Although a warning message is generated, users can proceed with live guidance using a mispositioned L-arm. This can result in the display of an incorrect overlay and needle path.
The affected units were distributed worldwide, including in the US states of Florida, Idaho, Illinois, Indiana, Massachusetts, and Ohio, as well as in Canada, Australia, Austria, Belgium, Germany, the Netherlands, New Zealand, South Africa, Switzerland, and Thailand. Users should contact Philips for instructions on how to resolve the issue.
The recalled product
- Product
- Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079
- Manufacturer
- Philips North America, LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 200
- 909
- 1276
- 1309
- 1330
- 703424
Distribution
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