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Class 2 Device Recall Optimus |
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Date Initiated by Firm |
February 24, 2005 |
Date Posted |
November 08, 2005 |
Recall Status1 |
Terminated 3 on September 27, 2010 |
Recall Number |
Z-1084-05 |
Recall Event ID |
33411 |
510(K)Number |
K945278
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Product Classification |
System, X-Ray, Stationary - Product Code KPR
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Product |
Optimus 30 |
Code Information |
serial #s - G15733, G15704, G15729, G14262, G15750, G15500, G15726, G14065, G15516, G15622, G14118, G14504, G15525, G15551, G14444, G14445, G14406, G15810, G15855, G16651, G16167, G15861, G15858, G15921, G15974, G16132, G16567, G16678, G17593, G16259, G16146, G16573, G17052, G17556, G17504, G16347, G17520, G17506, G17400, G17773, G17774, G17403, G16393. One unit identified with site #103950. |
Recalling Firm/ Manufacturer |
Philips Ultrasound, Inc. 22100 Bothell-Everett Hwy. P.O. Box 3003 Bothell WA 98041-3003
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For Additional Information Contact |
Sarah Baxter 425-487-7665
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Manufacturer Reason for Recall |
Systems do not comply with the labeling performance standards.
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FDA Determined Cause 2 |
Other |
Action |
On/about 2/24/04 the firm''s representatives began visiting sites to apply appropriate labeling. The firrm''s representatives will test units to verify compliance. |
Quantity in Commerce |
44 units |
Distribution |
Devices were distributed to 38 medical centers and hospitals throughout the US. |
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 = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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