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 | K033737 K041949 |
Product Classification |
System, X-Ray, Angiographic - Product Code IZI
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = IZI 510(K)s with Product Code = IZI
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