Recall Z-0475-2013— Philips Healthcare Inc.

Name: FDA recall Z-0475-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-30

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare Inc., initiated 2012-10-30, terminated 2017-01-17. It names one FDA 510(k) clearance: K982795. Product: Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics. Reason: With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "Right patient side" marker, although this can appear on the left patient side..

Recalling firm: Philips Healthcare Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-10-30
Terminated: 2017-01-17
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 Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics

Reason for recall

With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "Right patient side" marker, although this can appear on the left patient side.

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