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U.S. Department of Health and Human Services

Class 3 Device Recall SONOLINE Antares

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 Class 3 Device Recall SONOLINE Antaressee related information
Date Initiated by FirmSeptember 05, 2003
Date PostedOctober 15, 2003
Recall Status1 Terminated 3 on January 29, 2004
Recall NumberZ-0041-04
Recall Event ID 26509
510(K)NumberK001400 
ProductSONOLINE Antares Diagnostic Ultrasound System.
Code Information 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  
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
22010 SE 51st Street
Issaquah WA 98029-7298
For Additional Information Contact
425-392-9180
Manufacturer Reason
for Recall		Product labeling failed to include complete information about ALARA (As Low As Reasonably Achievable) safety instructions.
FDA Determined
Cause 2		Other
ActionOn 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 Commerce136 units
DistributionThe firm distributed units to 37 hospitals and medical centers nationwide. International distribution includes No military or government distribution.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code =
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