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Terminated

Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system

FDA Recall Z-1821-2012 · Posted 2012-06-18

Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeIXR
Date Initiated2012-05-11
Date Terminated2016-10-06
Product Quantity6

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

6 US customers

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031535PHILIPS EASYDIAGNOST ELEVAPhilips Medical Systems North America Co. · 2003-06-17K970640PHILIPS EASY DIAGNOSTPhilips Medical Systems North America, Inc. · 1997-03-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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