Class 2 Device Recall Optimus

• Date Initiated by Firm: February 24, 2005
• Date Posted: November 08, 2005
• Recall Status: Terminated on September 27, 2010
• Recall Number: Z-1084-05
• Recall Event ID: 33411
• 510(K)Number: K945278
• Product Classification: System, X-Ray, Stationary - Product Code KPR
• 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.
• FEI Number: 3019216
• Recalling Firm/ Manufacturer: Philips Ultrasound, Inc.; 22100 Bothell-Everett Hwy.; P.O. Box 3003; Bothell WA 98041-3003
• For Additional Information Contact: Sarah Baxter; 425-487-7665
• Manufacturer Reason for Recall: Systems do not comply with the labeling performance standards.
• FDA Determined Cause: 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

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 = KPR