Z-2512-2024 Class II Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
August 14, 2024
Initiation Date
June 28, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
400 units

Product Description

Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300

Reason for Recall

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the PST 500 U Precision Surgical Table due to a potential issue with loose spring pins in the spindle drives. This can cause the tabletop to unexpectedly tilt or move at any time, even without active use of the surgical table. This could potentially result in unintentional patient movement during surgical procedures and/or preparation for surgical procedures, including transport.

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Code Information

UDI/DI 00887761973671, Serial Numbers: 107936298, 107936299, 107936300, 107946575, 107946576, 107949857, 107951075, 107952514, 107954982, 108021169, 108023287, 108028575, 108028716, 108028747, 108028798, 108028801, 108028803, 108028817, 108028829, 108028840, 108028846, 108029046, 108029052, 108029053, 108049023, 108049024, 108049948, 108049950, 108049955, 108049967, 108050823, 108050824, 108055575, 108055576, 108055577, 108055581, 108123400, 108127380, 108129826, 108129828, 108131719, 108131745, 108133272, 108133273, 108160433, 108160447, 108160448, 108160452, 108160453, 108160454, 108160455, 108167451, 108167552, 108167553, 108167554, 108167561, 108167597, 108167598, 108167701, 108167702, 108167706, 108167710, 108167715, 108167719, 108167723, 108260659, 108260711, 108260712, 108260713, 108260749, 108260750, 108260756, 108260757, 108260768, 108260769, 108260770, 108260771, 108260772, 108260910, 108260912, 108260913, 108260914, 108260915, 108260922, 108260925, 108260926, 108260927, 108260929, 108260933, 108260934, 108260935, 108260936, 108260937, 108294079, 108294080, 108294081, 108294082, 108294083, 108294084, 108294085, 108296714, 108296720, 108296734, 108296735, 108296736, 108296737, 108296738, 108296739, 108296740, 108296741, 108296742, 108296743, 108296744, 108296745, 108310315, 108310316, 108310317, 108310318, 108310320, 108310321, 108310322, 108339152, 108339153, 108339154, 108339155, 108339156, 108339157, 108339158, 108352860, 108352861, 108352866, 108352870, 108352871, 108352879, 108352880, 108405249, 108405254, 108405255, 108405256, 108405257, 108405258, 108405261, 108420763, 108420764, 108420765, 108420766, 108420768, 108420769, 108420771, 108420773, 108420774, 108420775, 108420776, 108420777, 108420778, 108424302, 108424303, 108424306, 108424307, 108424315, 108424319, 108424320, 108438647, 108438648, 108438649, 108438650, 108438651, 108438652, 108438653, 108438654, 108438655, 108438656, 108438657, 108438678, 108438679, 108438680, 108454096, 108454097, 108454098, 108454099, 108454100, 108454101, 108454102, 108454103, 108454104, 108454105, 108454107, 108454108, 108454109, 108454110, 108518865, 108518871, 108518874, 108518875, 108518876, 108518877, 108631117, 108632551, 108634378, 108634380, 108634381, 108634384, 108634385, 108634388, 108634389, 108635878, 108635879, 108635880, 108635881, 108635882, 108649032, 108649033, 108649034, 108649035, 108649038, 108649040, 108649044, 108649049, 108649050, 108649051, 108649058, 108664845, 108664846, 108664847, 108664873, 108664874, 108664875, 108672929, 108672930, 108672934, 108672935, 108672936, 108672937, 108672941, 108943986, 108943988, 108943989, 108950971, 108950972, 108950979, 108950986, 108950987, 108950988, 108950989, 108950995, 108951002, 108951003, 108951033, 108951034, 108951035, 108951036, 108965785, 108965786, 108965787, 108965788, 108965789, 108967282, 108967283, 108967286, 108967287, 108967288, 108978908, 108978909, 108978910, 108978911, 108978912, 108985822, 108985823, 108985824, 108985825, 108985826, 108985964, 108985965, 108985966, 108985967, 108985968, 109061370, 109061372, 109061373, 109061374, 109061375, 109087781, 109087782, 109087783, 109087784, 109087796, 109087797, 109087798, 109087799, 109087800, 109087803, 109087884, 109087885, 109087886, 109087890, 109087891, 109101230, 109101231, 109101232, 109101233, 109101234, 109101252, 109101253, 109101254, 109101257, 109101258, 109111495, 109111498, 109111505, 109111506, 109111507, 109111508, 109111509, 109111695, 109111697, 109111698, 109113139, 109113140, 109113364, 109113367, 109113368, 109126203, 109126204, 109126205, 109126206, 109126207, 109126208, 109126209, 109126210, 109126211, 109126212, 109126213, 109126402, 109126403, 109126404, 109126405, 109126406, 109126413, 109126414, 109126435, 109126436, 109126515, 109126516, 109126517, 109126518, 109126519, 109148128, 109148129, 109148130, 109148131, 109148138, 109148147, 109148148, 109148149, 109148151, 109148152, 109167196, 109167198, 109167200, 109167202, 109167205, 109390924, 109390925, 109390926, 109390927, 109390928, 109393973, 109393974, 109393975, 109393980, 109394015, 109395299, 109395300, 109395301, 109395302, 109395303, 109410825, 109410931, 109410935, 109410943, 109410945, 109421725, 109421726, 109421728, 109421732, 109422488, 109425963, 109425965, 109425966, 109425967, 109425968, 109443678, 109443691, 109443758, 109456513, 109456516, 109462923, 109462925, 109518462, 108050823A