Recall Z-2059-2013— Philips Healthcare Inc.

Name: FDA recall Z-2059-2013
Creator: U.S. Food and Drug Administration
Published: 2013-08-08

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare Inc., initiated 2013-08-08, terminated 2020-09-03. It names one FDA 510(k) clearance: K982795. Product: Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.. 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: 2013-08-08
Terminated: 2020-09-03
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K982795 — PHILIPS BUCKY VISIONPhilips Medical Systems, Inc.·cleared 1998-11-24

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 Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.

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.