Optimus 30
This recall has been terminated (originally issued November 8, 2005).
- Company
- Philips Ultrasound, Inc.
- Recall Initiated
- February 24, 2005
- Posted
- November 8, 2005
- Terminated
- September 27, 2010
- Recall Number
- Z-1084-05
- Quantity
- 44 units
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
Systems do not comply with the labeling performance standards.
Distribution
Devices were distributed to 38 medical centers and hospitals throughout the US.
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.
Root Cause
Other
Action Taken
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.