Z-0041-04

SONOLINE Antares Diagnostic Ultrasound System

Name: Z-0041-04 SONOLINE Antares Diagnostic Ultrasound System
Creator: Siemens Medical Solutions USA, Inc.
Published: 2003-09-05
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2003-09-05 / Terminated / root cause: labeling and UDI

FDA source

Siemens Medical Solutions USA, Inc. began a recall of SONOLINE Antares Diagnostic Ultrasound System on 2003-09-05. The reason FDA records is "Product labeling failed to include complete information about ALARA (As Low As Reasonably Achievable) safety instructions". 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-0041-04
Status: Terminated
Initiated: 2003-09-05
Posted: 2003-10-15
Terminated: 2004-01-29
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SONOLINE Antares Diagnostic Ultrasound System.
Reason for recall: Product labeling failed to include complete information about ALARA (As Low As Reasonably Achievable) safety instructions.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: On 9/5/03 the firm issued a letter dated September 2003 via overnight delivery. The letter states that a CD-Rom is included that provides a new manual that is to replace the previous manual. The new manual provides information that was previously omitted regarding the ALARA information.
Quantity in commerce: 136 units
Distribution: The firm distributed units to 37 hospitals and medical centers nationwide. International distribution includes No military or government distribution.
Product codes and lots: Catalog No. 5936518, 7035415, 5936682, 5936682, 5936708, 5936716, 5936724 Serial numbers: 10106, 10107, 10108, 10253, 10323, 10347, 10352, 10392, 10393, 10394, 10407, 10429, 10430, 10431, 10462, 10465, 10470, 10475, 10492, 10504, 10511, 10535, 10540, 10541, 10542, 10543, 10576, 10585, 10611, 10614, 10626, 10651, 10662, 10712, 10724, 10727, 10745, 10819, 10829, 10837, 10843, 10848, 10849, 10850, 10851, 10852, 10861, 10869, 10873, 10875, 10921, 11008, 11022, 11025, 11049, 11050, 11051, 11053, 11054, 11071, 11102, 11104, 10012, 10027, 10195, 10471, 10483, 10484, 10491, 10583, 10664, 10703, 11033, 11034, 10781, 10432, 10257, 10262, 10274, 10281, 10338, 10383, 10493, 10686, 10836, 10847, 11009, 11030, 11057, 10400, 10401, 10453, 10466, 10737, 10752, 10777, 10778, 10784, 11027, 11028, 11029, 10286, 10602, 10753, 10923, 10018, 10058, 10071, 10116, 10434 , 10668, 10970, 10351, 10697, 10991, 10997, 10277, 10681, 11073, 10130, 10267, 10782, 11002, 11019, 11032, 11072, 10648

K001400Class IIElegra Millennium Enhanced Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. / cleared 2000-08-01

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)