—#27809

Product

SONOLINE Antares Diagnostic Ultrasound System.

510(k) numbers: K001400
Affected lot / code info: 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

Why it was recalled

Product labeling failed to include complete information about ALARA (As Low As Reasonably Achievable) safety instructions.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 22010 SE 51st Street, Issaquah, Washington 98029-7298

Distribution

Distribution pattern: The firm distributed units to 37 hospitals and medical centers nationwide. International distribution includes No military or government distribution.

Timeline

Recall initiated: 2003-09-05
Posted by FDA: 2003-10-15
Terminated: 2004-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #27809. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.