Philips Healthcare Inc.: Medical Device Recall in 2012 - (Recall #: Z-1821-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system

Product Classification:

Class II

Date Initiated: May 11, 2012

Date Posted: June 27, 2012

Recall Number: Z-1821-2012

Event ID: 61877

Reason for Recall:

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

Status: Terminated

Product Quantity: 6

Code Information:

All systems with Eleva software version 4.x and stitching option.

Distribution Pattern:

6 US customers

Voluntary or Mandated:

Voluntary: Firm initiated