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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm October 12, 2005
Date Posted November 29, 2005
Recall Status1 Terminated 3 on March 09, 2011
Recall Number Z-0209-06
Recall Event ID 33873
510(K)Number K041949  K033737  
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product AD6 table, modified, used with the XPER systems. The modification on the table is the cables used for connecting to the XPER systems.
Code Information see site numbers listed above
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact Sarah Baxter
425-487-7665
Manufacturer Reason
for Recall
Potential for high voltage exposure involving the injector interface connector of patient support tables.
FDA Determined
Cause 2
Other
Action On 10/10/05 the firm issued a letter to customers alerting customers to the problem and advising that the firm will perform an upgrade to the devices at customer sites. In March 2006 the firm issued a second notification letter involving more units.
Quantity in Commerce see total above
Distribution Devices were distributed nationwide to hospitals/medical centers.
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 CO.
510(K)s with Product Code = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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