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U.S. Department of Health and Human Services

Class 2 Device Recall PHILIPS EASYDIAGNOST ELEVA

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  Class 2 Device Recall PHILIPS EASYDIAGNOST ELEVA see related information
Date Initiated by Firm July 14, 2017
Create Date January 03, 2018
Recall Status1 Terminated 3 on June 05, 2020
Recall Number Z-0311-2018
Recall Event ID 78833
510(K)Number K031535  
Product Classification System, x-ray, stationary - Product Code KPR
Product Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid.
Code Information 9890-010-88152 - Codes included in attached list. Devices were manufactured and distributed from March 2015 - March 2017.
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Karmen Gruenert
800-722-9377
Manufacturer Reason
for Recall		 If the lock mechanism of the movable camp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is applied. This may happen when the detector is rotated clockwise from landscape to portrait position.
FDA Determined
Cause 2		 Under Investigation by firm
Action If the lock mechanism of the movable clamp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is . applied. This may happen when the detector is rotated clockwise from landscape to portrait position. The Wireless Portable Detector (WPD) is fixed in the Mobile Detector Holder via a lock mechanisrn. The 4 countersunk screws, that are used to attach the lock mechanism, can become loose. If this happens and the mechanism fails, the detector may fall down when the holder is rotated 90 clockwise from Iandscape.
Quantity in Commerce 412
Distribution 412 units affected.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
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