Recall Z-0766-2016— Philips Electronics North America Corporation

Name: FDA recall Z-0766-2016
Creator: U.S. Food and Drug Administration
Published: 2015-07-22

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2015-07-22, terminated 2020-10-14. It names one FDA 510(k) clearance: K945278. Product: Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.. Reason: If arm is not fastened securely it could fall down..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-07-22
Terminated: 2020-10-14
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 Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.

Reason for recall

If arm is not fastened securely it could fall down.

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