FDA Medical Device Recalls (openFDA)
Philips Ultrasound, Inc.: Optimus 30
- Recall number
- Z-1084-05
- Recalling firm
- Philips Ultrasound, Inc.
- Product
- Optimus 30
- Status
- Terminated
- Initiated
- 2005-02-24
- Posted
- 2005-11-08
- Terminated
- 2010-09-27
- Reason
- Systems do not comply with the labeling performance standards.
- Root 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
- 44 units
- Distribution
- Devices were distributed to 38 medical centers and hospitals throughout the US.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K945278"]
- PMA numbers
- not on file
- Product code
- KPR
- Firm FEI
- 3019216
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28