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U.S. Department of Health and Human Services

Class 2 Device Recall Urodiagnost Eleva

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  Class 2 Device Recall Urodiagnost Eleva see related information
Date Initiated by Firm February 28, 2019
Create Date March 23, 2019
Recall Status1 Terminated 3 on August 03, 2020
Recall Number Z-1056-2019
Recall Event ID 82313
510(K)Number K032046  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product URODiagnost Eleva, Product codes 708026, 708027, 708028

Product Usage:
The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and non-subtracted digital imaginginclude: Angiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.
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Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Roland Telson
978-659-7275
Manufacturer Reason
for Recall		 The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
FDA Determined
Cause 2		 Component design/selection
Action On February 28, 2019, the firm notified customers via an Urgent Field Safety Notice letter. The letter informed customers that the affected systems would be inspected for missing locking plates. Customers were asked to place a copy of the Field Safety Notice with the documentation of the system until the system has been inspected by Philips. Philips will inspect all potentially affected systems free of charge. If a locking plate is found missing, Philips will secure the system until a locking plate is installed so that use of the system can continue. You will be contacted by your local Philips representative to schedule the inspection. Philip's action will start effective from March 2019. If you need further information or support concerning this issue, please contact your local Philips representative.
Quantity in Commerce 1969
Distribution US Nationwide domestic distribution, and worldwide international distribution.
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 = OWB and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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