Recall Z-1821-2012— Philips Healthcare Inc.

Name: FDA recall Z-1821-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-11

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare Inc., initiated 2012-05-11, terminated 2016-10-06. It names 2 FDA 510(k) clearances: K031535, K970640. 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.

Recalling firm: Philips Healthcare Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-05-11
Terminated: 2016-10-06
Firm location: Andover, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K031535 — PHILIPS EASYDIAGNOST ELEVAPhilips Medical Systems North America Co.·cleared 2003-06-17
K970640 — PHILIPS EASY DIAGNOSTPhilips Medical Systems North America, Inc.·cleared 1997-03-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.