Device recalls

TruSystem 7500 Hybrid Plus (FC), Fixed-Installation Operating Table Column, Model/Catalog Number: 1854087

Baxter Healthcare Corporation · There is an issue with the main lift mechanism. The main lift may unexpectedly drop from its set position to its lowest position during use. In these cases, th…

Open, ClassifiedNonconforming Material/ComponentZ-0354-2027
Open FDA's page for this record
Cfres ID
223356
Product res number
Z-0354-2027
Event date initiated
2026-09-29
Event date posted
2026-11-03
Recall status
Open, Classified
Res event number
100117
Product code
GDC
Product description
TruSystem 7500 Hybrid Plus (FC), Fixed-Installation Operating Table Column, Model/Catalog Number: 1854087
Code info
Serial numbers: 107971925; UDI-DI number: 00887761974067
Firm FEI number
1417572
Recalling firm
Baxter Healthcare Corporation
Address 1
1 Baxter Pkwy
City
Deerfield
State
IL
Postal code
60015-4625
Additional info contact
Center for One Baxter 1-847-948-4770
Root cause description
Nonconforming Material/Component
Product quantity
1 unit
Distribution pattern
Worldwide - US Nationwide distribution.
Reason for recall

There is an issue with the main lift mechanism. The main lift may unexpectedly drop from its set position to its lowest position during use. In these cases, the tabletop could not be raised again after the drop occurred. The issue has been associated with unexpected wear of the main lift assembly, also known as the telescopic spindle. An uncontrolled drop of the surgical table may result in an abrupt patient displacement during surgery. Serious or critical adverse health consequences may occur, including traumatic injury, airway compromise, and surgical procedure complications, among others. Baxter has received three complaints related to this issue, with no reported patient injury.

Action

An URGENT MEDICAL DEVICE CORRECTION notification letter dated 9/29/26 was sent to customers. Actions to be Taken by Customers 1. A Baxter representative will contact your facility when the correction for this issue becomes available. Baxter expects to begin contacting customers with more information about the correction by the end of 2026. 2. Customers should continue to monitor the table as instructed in the applicable IFU during use for unusual noises or changes in performance. If an unusual noise is observed, discontinue use of the affected product and contact Baxter Technical Service for assistance. 3. Please post this communication by the impacted devices until the correction is completed to maintain user awareness. 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. Log in to the portal using the account number listed in the enclosed reply instruction sheet. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from Accenture LLP on behalf of Baxter to confirm your receipt of this notification. 5. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions. 6. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. 7. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures and check the associated box o

Harmonized identifiers (openFDA)
Device name
Table, Operating-Room, Electrical
Medical specialty description
General, Plastic Surgery
Regulation number
878.4960
Device class
1
K number
K821665, K853720, K964273, K940616, K915393, K843134, K821749, K851830, K883613, K853480, K851021, K853535, K851829, K850168, K914758, K934744, K971390, K970807
Registration number
3003912946, 3012165496, 3010202439, 3010594257, 3007417753, 3003574554, 3030516433, 3011537487, 3009567010, 3003696170, 3030681105, 3006063136, 3027520367, 3029970239, 3010446656, 1836161, 3031582440, 3008881803, 1643264, 3010373263, 3010326005, 3011659880, 3007143268, 3013774640, 3006975482, 3008388379, 3003898943, 1825014, 3023449169, 9681454, 3006142326, 3030194752, 3003604053, 1066635, 3043177791, 3011547624, 3006897996, 3007238566, 3007123908, 9710385 +76 more
FEI number
3003912946, 3012165496, 3010594257, 3007417753, 3003574554, 3030516433, 3011537487, 3009567010, 3003696170, 3030681105, 3006063136, 3027520367, 3004574120, 3029970239, 3009504761, 3010446656, 3031582440, 3008881803, 1643264, 3010373263, 3010326005, 3002572935, 3003138129, 3011659880, 3002808001, 3007475226, 3007143268, 3007513035, 3013774640, 3006975482, 3008388379, 3003898943, 1825014, 3023449169, 3006142326, 3030194752, 3003604053, 3003184737, 3043177791, 3011547624 +76 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.