Z-2512-2024Class II

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

Name: Z-2512-2024 Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
Creator: Baxter Healthcare Corporation
Published: 2024-06-28
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-06-28 / Open, Classified

FDA source

Baxter Healthcare Corporation began a recall of Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300 on 2024-06-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2512-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-28
Posted: 2024-08-06
Recalling firm: Baxter Healthcare Corporation
Product: Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
Product code: GDC Table, Operating-Room, Electrical
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.
FDA root cause: Under Investigation by firm
Action: 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
Quantity in commerce: 400 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2512-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2512-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-06

Product code GDC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)