Recall Z-0508-2015— Philips Medical Systems, Inc.

Name: FDA recall Z-0508-2015
Creator: U.S. Food and Drug Administration
Published: 2014-04-08

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-04-08, terminated 2018-05-31. It names one FDA 510(k) clearance: K111725. Product: Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with the patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.. Reason: In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur..

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-04-08
Terminated: 2018-05-31
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K111725 — MOBILEDIAGNOST WDRSedecal., Sa.·cleared 2011-07-19

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

Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with the patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.

Reason for recall

In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur.

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