Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system — Class II medical device recall Z-1821-2012
Terminated recall by Philips Healthcare Inc., reported 2012-06-27. If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured ob
| Recall number | Z-1821-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare Inc., Andover, MA, United States |
| Recall initiated | 2012-05-11 |
| Classified | 2012-06-18 |
| Reported by FDA | 2012-06-27 |
| Terminated | 2016-10-06 |
| Quantity | 6 |
Product
Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1821-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.