FDAFDA · Food and drugs·Recall number Z-0767-2013
Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
Published February 13, 2013 · Recall initiated: January 16, 2013
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
The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Healthcare Inc.
- Distributor
- US Nationwide Distribution including the states of FL, CA, WA, AZ, NC, KY, DE, AZ and MO.
- Lot
- Serial Numbers 362600, 362601, 364209, 364210, 375245, 375850, 376439, 384396, 387492, 398185, 399440, 399621, 399623, 402409
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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