Recall Z-1450-2013— Philips Healthcare Inc.

Name: FDA recall Z-1450-2013
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 2013-10-15. It names one FDA 510(k) clearance: K945278. Product: Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics. Reason: An inspection of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) 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: 2013-10-15
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K945278 — PHILIPS BUCKY DIAGNOST FAMILYPhilips Medical Systems North America, Inc.·cleared 1994-12-14

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 BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics

Reason for recall

An inspection of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) 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.