Device product
Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
Z-1821-2012
Product summary
- Event
- Event 61877
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6
- Official record key
device-enforcement:Z-1821-2012
Official wording
Reason: 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
Code information: All systems with Eleva software version 4.x and stitching option.
Distribution pattern: 6 US customers
Derived failure modes
-
Unknown
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