Recall Z-1044-2015— Philips Medical Systems, Inc.

Name: FDA recall Z-1044-2015
Creator: U.S. Food and Drug Administration
Published: 2013-10-14

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2013-10-14, terminated 2017-01-23. It names one FDA 510(k) clearance: K023441. Product: Philips Multi Diagnost Eleva II. Reason: The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected..

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-14
Terminated: 2017-01-23
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K023441 — PHILIPS MULTIDIAGNOST ELEVAPhilips Medical Systems·cleared 2002-10-30

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

Philips Multi Diagnost Eleva II

Reason for recall

The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.

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