Home / Recalls / Medical Devices
Philips Healthcare Inc. recalls Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
Recalled June 27, 2012 · FDA recall Z-1821-2012 · Philips Healthcare
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 · FDA Class II
Units
6
Sold at
6 US customers
Description
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
Product
Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
Manufacturer(s)
Philips Healthcare Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →