Recall Z-0767-2013— Philips Healthcare Inc.

Name: FDA recall Z-0767-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-16

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare Inc., initiated 2013-01-16, terminated 2017-01-23. It names one FDA 510(k) clearance: K031535. Product: Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications. Reason: The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system..

Recalling firm: Philips Healthcare Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-01-16
Terminated: 2017-01-23
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K031535 — PHILIPS EASYDIAGNOST ELEVAPhilips Medical Systems North America Co.·cleared 2003-06-17

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

Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications

Reason for recall

The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.

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