Recall Z-1806-2020— Philips North America, LLC

Name: FDA recall Z-1806-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-07

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2020-04-07, terminated 2023-04-28. It names one FDA 510(k) clearance: K945278. Product: Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.. Reason: If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-04-07
Terminated: 2023-04-28
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 TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.

Reason for recall

If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.

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