Device product
Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
Z-2512-2024
Product summary
- Event
- Event 94944
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 400 units
- Official record key
device-enforcement:Z-2512-2024
Official wording
Reason: 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.
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
Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.
Derived failure modes
-
Unknown
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.