Recall Z-1447-2013— Philips Healthcare Inc.

Name: FDA recall Z-1447-2013
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 2016-09-30. It names one FDA 510(k) clearance: K982795. Product: Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications. Reason: Installation Acceptance Test Document (IATD) non compliant with regulations IATDs (Installation Acceptance Test could not be located or different templates have been used.

Recalling firm: Philips Healthcare Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-01-16
Terminated: 2016-09-30
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 Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications

Reason for recall

Installation Acceptance Test Document (IATD) non compliant with regulations IATDs (Installation Acceptance Test could not be located or different templates have been used

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