Recall Z-0612-2019— Philips Medical Systems Gmbh, DMC

Name: FDA recall Z-0612-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-07

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems Gmbh, DMC, initiated 2018-11-07, terminated 2020-09-02. It names one FDA 510(k) clearance: K163210. Product: Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System. Reason: kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose..

Recalling firm: Philips Medical Systems Gmbh, DMC
Classification: Class II
Status: Terminated
Initiated: 2018-11-07
Terminated: 2020-09-02
Firm location: Hamburg, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K163210 — Philips CombiDiagnost R90Philips Medical Systems Dmc GmbH·cleared 2017-01-31

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

Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System

Reason for recall

kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.

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