Recall Z-2322-2017— Philips Electronics North America Corporation

Name: FDA recall Z-2322-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-31

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2017-05-31, terminated 2018-08-24. It names one FDA 510(k) clearance: K141381. Product: Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Product Number 712211). Reason: Tube arm assembly could fall down due to cracked welding joints.

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-05-31
Terminated: 2018-08-24
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K141381 — DURADIAGNOSTPhilips Healthcare (Suzhou) Co., Ltd.·cleared 2014-06-12

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 DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Product Number 712211)

Reason for recall

Tube arm assembly could fall down due to cracked welding joints

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