FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc.: SONOLINE Antares Diagnostic Ultrasound System.
- Recall number
- Z-0041-04
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Product
- SONOLINE Antares Diagnostic Ultrasound System.
- Status
- Terminated
- Initiated
- 2003-09-05
- Posted
- 2003-10-15
- Terminated
- 2004-01-29
- Reason
- Product labeling failed to include complete information about ALARA (As Low As Reasonably Achievable) safety instructions.
- 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
- 136 units
- Distribution
- The firm distributed units to 37 hospitals and medical centers nationwide. International distribution includes No military or government distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K001400"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 3023245
- Firm city
- Issaquah
- 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