Recalls / —

—#41820

Product

Optimus 30

FDA product code

KPR — System, X-Ray, Stationary

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K945278

Affected lot / code info

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.

Why it was recalled

Systems do not comply with the labeling performance standards.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Philips Ultrasound, Inc.

Address

22100 Bothell-Everett Hwy. P.O. Box 3003, Bothell, Washington 98041-3003

Distribution

Distribution pattern

Devices were distributed to 38 medical centers and hospitals throughout the US.

Timeline

Recall initiated

2005-02-24

Posted by FDA

2005-11-08

Terminated

2010-09-27

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #41820. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.