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U.S. Department of Health and Human Services

Class 2 Device Recall Integris Allura

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  Class 2 Device Recall Integris Allura see related information
Date Initiated by Firm December 14, 2006
Date Posted January 25, 2007
Recall Status1 Terminated 3 on October 14, 2011
Recall Number Z-0370-2007
Recall Event ID 37012
510(K)Number K031333  
Product Classification angiographic x-ray systems - Product Code IZI
Product FD 10/10 X-Ray System, Angiograph, bi-plane digital Allura FD, 10' detector
Code Information site numbers provided in the product listing for Z-0366-2007
Recalling Firm/
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact Sarah Baxter
Manufacturer Reason
for Recall
Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.
FDA Determined
Cause 2
Action On 12/14/05 and 12/20/06 the firm issued a letter dated 12/12/06 to their customers. The letter explains the problem and states that the firm will be performing mandatory upgrades to correct the situation. Consignees will be contacted to arrange for service.
Quantity in Commerce 140 devices total
Distribution Units were distributed to hospitals and medical centers nationwide.
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 = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.