Z-1821-2012Class II

Philips Easy Diagnost

Name: Z-1821-2012 Philips Easy Diagnost
Creator: Philips Healthcare Inc.
Published: 2012-05-11
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-05-11 / Terminated / root cause: design

FDA source

Philips Healthcare Inc. began a recall of Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system on 2012-05-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1821-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-11
Posted: 2012-06-18
Terminated: 2016-10-06
Recalling firm: Philips North America LLC
Product: Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
Product code: IXR Table, Radiographic, Tilting
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
Root cause tag: design
FDA root cause: Device Design
Action: Philips sent an Urgent - Field Safety Notice letter dated May 11, 2012 to their affected customers. The letter identified the affected product, what the issues are, under what circumstances they may occur and the actions to be taken to avoid or minimize the occurrence of the issue Philips plans to supply an Addendum to the Instruction for Use. A Philips Service Engineer will contact the affected customers as soon as the Field Action Kit is ready to be implemented. For questions contact your local Philips representative: Technical Support Line 1-800-722-9377.
Quantity in commerce: 6
Distribution: 6 US customers
Product codes and lots: All systems with Eleva software version 4.x and stitching option.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1821-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1821-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-18

Product code IXR

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)