Recall Z-2523-2020— Philips North America, LLC

Name: FDA recall Z-2523-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-02

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2020-06-02, terminated 2021-02-09. It names one FDA 510(k) clearance: K031535. Product: EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.. Reason: Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-06-02
Terminated: 2021-02-09
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K031535 — PHILIPS EASYDIAGNOST ELEVAPhilips Medical Systems North America Co.·cleared 2003-06-17

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

EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.

Reason for recall

Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction.

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