FDAFDA · Food and drugs·Recall number Z-0022-2015
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Published October 15, 2014 · Recall initiated: August 8, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Philips had discovered through a field service testing where a device failed to comply with a Federal standard.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems, Inc.
- Distributor
- US distribution to FL
- Lot
- Model Number: Integris Allura 15-12 Serial Number: 16741023
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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