Reported Jun 27, 2012 · Terminated
Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
Philips Healthcare Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Healthcare Inc. · 3000 Minuteman Road · Andover, MA · 01810
Is this the product you have?
- Philips Easy Diagnost Product UsageStationary Fluoroscopic system
- Lot codes and dates
- All systems with Eleva software version 4.x and stitching option.
- Amount recalled
- 6
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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