Recall Z-1448-2013— Philips Healthcare Inc.

Name: FDA recall Z-1448-2013
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. Records shows table height measurements out of specification with the consequence of potential system mis-alignment..

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. Records shows table height measurements out of specification with the consequence of potential system mis-alignment.

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