Recall Z-2856-2018— Philips Medical Systems Gmbh, DMC

Name: FDA recall Z-2856-2018
Creator: U.S. Food and Drug Administration
Published: 2018-06-27

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems Gmbh, DMC, initiated 2018-06-27, terminated 2024-04-30. It names one FDA 510(k) clearance: K090625. Product: DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081. Reason: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient..

Recalling firm: Philips Medical Systems Gmbh, DMC
Classification: Class II
Status: Terminated
Initiated: 2018-06-27
Terminated: 2024-04-30
Firm location: Hamburg, Germany

510(k) clearances named in this recall

1 on FDA's record

K090625 — WIRELESS PORTABLE DETECTOR FD-W17Philips Medical Systems North America Co.·cleared 2009-03-24

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

DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081

Reason for recall

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

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