Recall Z-2154-2017— Philips Electronics North America Corporation

Name: FDA recall Z-2154-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-11

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2017-05-11, terminated 2018-07-10. It names one FDA 510(k) clearance: K141736. Product: Philips DigitalDiagnost 3.1.x X-Ray System. Reason: During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-05-11
Terminated: 2018-07-10
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K141736 — PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOSTPhilips Medical Systems Dmc GmbH·cleared 2014-07-25

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 DigitalDiagnost 3.1.x X-Ray System

Reason for recall

During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions.

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