FDA Device recall Z-1821-2012
Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
- FDA Device
- Class II
- terminated
- Published 2012-06-27
On 2012-06-27 the FDA classified a Class II recall of Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system by Philips Healthcare, citing 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 fact….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1821-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-11 |
| Published | 2012-06-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Healthcare |
| Distribution | n/a |
Product
Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
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
Identifiers
| code_info | All systems with Eleva software version 4.x and stitching option. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1821-2012%22
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