Recall Z-1706-2017— Philips Healthcare Inc.

Name: FDA recall Z-1706-2017
Creator: U.S. Food and Drug Administration
Published: 2012-11-28

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare Inc., initiated 2012-11-28, terminated 2018-05-31. It names one FDA 510(k) clearance: K111725. Product: Mobile Diagnostic X-Ray System with Digital Panel. Reason: When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image..

Recalling firm: Philips Healthcare Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-11-28
Terminated: 2018-05-31
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K111725 — MOBILEDIAGNOST WDRSedecal., Sa.·cleared 2011-07-19

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

Mobile Diagnostic X-Ray System with Digital Panel

Reason for recall

When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image.

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