Recall Z-1555-2015— Philips Medical Systems, Inc.

Name: FDA recall Z-1555-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-09

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2015-02-09, terminated 2016-06-14. It names one FDA 510(k) clearance: K141381. Product: Philips Healthcare DuraDiagnost X- Ray. Reason: The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j)..

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-02-09
Terminated: 2016-06-14
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K141381 — DURADIAGNOSTPhilips Healthcare (Suzhou) Co., Ltd.·cleared 2014-06-12

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 Healthcare DuraDiagnost X- Ray

Reason for recall

The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j).

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