SONOLINE Antares Diagnostic Ultrasound System.
- Recall Initiated
- September 5, 2003
- Posted
- October 15, 2003
- Terminated
- January 29, 2004
- Recall Number
- Z-0041-04
- Quantity
- 136 units
- Firm Location
- Issaquah, WA
Reason for Recall
Product labeling failed to include complete information about ALARA (As Low As Reasonably Achievable) safety instructions.
Distribution
The firm distributed units to 37 hospitals and medical centers nationwide. International distribution includes No military or government distribution.
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
Root Cause
Other
Action Taken
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.