Medical Device Recall: Z-0041-04

FDA Recalls dataset · Firm: Siemens Medical Solutions USA, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2003-09-05 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0041-04.

Recall Res Number
Z-0041-04
Recalling Firm / Manufacturer
Siemens Medical Solutions USA, Inc.
FEI Number
3023245
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2003-09-05
Date Posted
2003-10-15
Date Terminated
2004-01-29
Product Code
N/A
Event Number
26509
Product Quantity
136 units
Product Description SONOLINE Antares Diagnostic Ultrasound System.
Reason for Recall Product labeling failed to include complete information about ALARA (As Low As Reasonably Achievable) safety instructions.
Action Details 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.
Distribution Pattern The firm distributed units to 37 hospitals and medical centers nationwide. International distribution includes No military or government distribution.
Code Information / Serial Numbers 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

Related Establishments / Registrations

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