—#208860

Product

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

FDA product code: GDC — Table, Operating-Room, Electrical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Baxter issued issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 06/28/2024 via USPS. The notice explained the problem with the device, hazard involved, and requested the following: Actions to be Taken by Customers 1. Immediately cease all use of the impacted units until a correction has been completed. If you have alternative tables available, please use them until the service kit is installed by the hospital technician, a Baxter technician, or an authorized representative. 2. Below are two options for correction of the impacted units: a. Self-installation of the service kit (part number 2086594) executed by a hospital-defined technician per the technical service bulletin included with the service kit. Once the self-installation is successful, the impacted units are ready for use. For any questions regarding the installation of the service kit, please contact Baxter Technical Support at 800-445-3720 (select option 2, then option 7) between 8:00 am and 6:00 pm Eastern Time, Monday through Friday. b. A Baxter representative will contact you to schedule inspection of self-corrected units or correct the impacted units at your facility. Do not use the impacted units until the correction has been executed. To request correction of your impacted tables, contact Baxter Technical Support at 800-445-3720 (select option 2, then option 7) between 8:00 am and 6:00 pm Eastern Time, Monday through Friday. 3. Please provide this information to all users of the PST 500 U Precision Surgical Table. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. 4. If you received this communication directly from Baxter, please acknowledge receipt of this notification by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any remaining inventory. Log in to the portal using the account number listed in the enclosed reply

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.

Timeline

Recall initiated: 2024-06-28
Posted by FDA: 2024-08-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208860. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.