Z-1084-05

Optimus 30

Name: Z-1084-05 Optimus 30
Creator: Philips Ultrasound, Inc.
Published: 2005-02-24
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2005-02-24 / Terminated / root cause: labeling and UDI

FDA source

Philips Ultrasound, Inc. began a recall of Optimus 30 on 2005-02-24. The reason FDA records is "Systems do not comply with the labeling performance standards". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1084-05
Status: Terminated
Initiated: 2005-02-24
Posted: 2005-11-08
Terminated: 2010-09-27
Recalling firm: Philips North America LLC
Product: Optimus 30
Product code: KPR System, X-Ray, Stationary
Reason for recall: Systems do not comply with the labeling performance standards.
Root cause tag: labeling and UDI
FDA 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 in commerce: 44 units
Distribution: Devices were distributed to 38 medical centers and hospitals throughout the US.
Product codes and lots: 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.

Product code KPR

K945278Class IIPhilips Bucky Diagnost FamilyPhilips Medical Systems North America, Inc. / cleared 1994-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)