Recall Z-1084-2016— Sedecal S.A.

Name: FDA recall Z-1084-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-18

Class II · Terminated

Class II FDA medical device recall by Sedecal S.A., initiated 2016-01-18, terminated 2018-02-07. It names one FDA 510(k) clearance: K111725. Product: Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on 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 patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.. Reason: This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Reason for Recall: Along with the previously noted encoder and gauges problems and corresponding fixes, we have observed that static electricity can also elicit the unwanted behavior..

Recalling firm: Sedecal S.A.
Classification: Class II
Status: Terminated
Initiated: 2016-01-18
Terminated: 2018-02-07
Firm location: Algete, N/A, Spain

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

Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on 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 patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.

Reason for recall

This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Reason for Recall: Along with the previously noted encoder and gauges problems and corresponding fixes, we have observed that static electricity can also elicit the unwanted behavior.

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