• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Cardiovascular Allura Centron

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Cardiovascular Allura Centron see related information
Date Initiated by Firm November 03, 2015
Date Posted January 30, 2016
Recall Status1 Terminated 3 on September 15, 2020
Recall Number Z-0716-2016
Recall Event ID 72599
510(K)Number K141979  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Cardiovascular Allura Centron; Model Number: 722400

The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250 kg.) with probable internal diseases or injuries for: " Dedicated vascular and carotid imaging applications, including diagnostic and interventional procedures. " Cardiac imaging applications including diagnostics, interventional rocedures, pacemaker implantations and electrophysiology (EP). " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.
Code Information All serial numbers
Recalling Firm/
Manufacturer
Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
800-722-9377
Manufacturer Reason
for Recall
The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
FDA Determined
Cause 2
Device Design
Action The firm, Philips, issued "URGENT-Field Safety Notices" dated 10/26/2015 and 11/19/2015 to its customers. The notices described the product, problem and actions to be taken. The customers were instructed to ensure the audible signal (X-ray buzzer) is always enabled, to activate only ONE fluoroscopy pedal at time, and to configure the footswitch to the default Philips configuration. Customers were also instructed to review the information with all members of your staff who need to be aware; retain a copy with the equipment IFU and complete and return the Confirmation Respond form to Mail Stop 4302, 3000 Minuteman Road, Andover, MA 01810 or email: Debra.Gibbs@Philips.com. Philips is tracking the delivery of these notices via certified return receipt. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.
Quantity in Commerce 13297 in total
Distribution Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.
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 NETHERLAND, B.V.
-
-