FDAFDA · Food and drugs·Recall number Z-1821-2012
Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
Published June 27, 2012 · Recall initiated: May 11, 2012
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
If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. If, additionally, the measurement tool is not used to check the ruler, or is used in the right way (ie: calibration), such calibration error is not detected. As a result of this, a surgical intervention may be execut
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Healthcare Inc.
- Distributor
- 6 US customers
- Lot
- All systems with Eleva software version 4.x and stitching option.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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