Recall Z-1606-2018— Philips Medical Systems Nederlands

Name: FDA recall Z-1606-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-26

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems Nederlands, initiated 2018-03-26, terminated 2020-06-12. It names one FDA 510(k) clearance: K050151. Product: Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.. Reason: The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user..

Recalling firm: Philips Medical Systems Nederlands
Classification: Class II
Status: Terminated
Initiated: 2018-03-26
Terminated: 2020-06-12
Firm location: Best, N/A, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K050151 — MULTIDIAGNOST ELEVAPhilips Medical Systems North America, Inc.·cleared 2005-02-09

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

Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

Reason for recall

The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.

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