Recall Z-0365-2016— Philips Medical Systems, Inc.

Name: FDA recall Z-0365-2016
Creator: U.S. Food and Drug Administration
Published: 2014-08-19

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-08-19, terminated 2016-06-14. It names one FDA 510(k) clearance: K031535. Product: Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050. Reason: The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient..

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-08-19
Terminated: 2016-06-14
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

Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050

Reason for recall

The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.

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