Recall Z-1695-2016— Philips Healthcare

Name: FDA recall Z-1695-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-10

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare, initiated 2015-11-10, terminated 2017-05-03. It names one FDA 510(k) clearance: K141736. Product: Philips Healthcare DigitalDiagnost stationary X-ray system. Reason: The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image..

Recalling firm: Philips Healthcare
Classification: Class II
Status: Terminated
Initiated: 2015-11-10
Terminated: 2017-05-03
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 Healthcare DigitalDiagnost stationary X-ray system

Reason for recall

The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.

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