Device recalls

TruSystem 7000 U Operating Table (dV), Product Code 1723633

Baxter Healthcare Corporation · The main lift may unexpectedly drop from its set position to its lowest position during use. The tabletop may not be able to be raised again after the drop occ…

Open, ClassifiedEquipment maintenanceZ-0332-2027
Open FDA's page for this record
Cfres ID
223130
Product res number
Z-0332-2027
Event date initiated
2026-09-14
Event date posted
2026-11-03
Recall status
Open, Classified
Res event number
99826
Product code
GDC
Product description
TruSystem 7000 U Operating Table (dV), Product Code 1723633
Code info
UDI-DI: 00887761967519; Serial Number: 110188921, 110188922, and 110206662
Firm FEI number
1416980
Recalling firm
Baxter Healthcare Corporation
Address 1
25212 W Il Route 120
City
Round Lake
State
IL
Postal code
60073-9799
Additional info contact
Center for One Baxter 1-847-9484770
Root cause description
Equipment maintenance
Product quantity
62 units
Distribution pattern
US Nationwide distribution in the states of IL, MO, TX.
Reason for recall

The main lift may unexpectedly drop from its set position to its lowest position during use. The tabletop may not be able to be raised again after the drop occurs. 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.

Action

Customers were notified by telephone beginning 9/14/26. Baxter Healthcare Corporation is issuing a voluntary correction for the TruSystem Surgical Tables after identifying that four units underwent spindle replacement without the required belt tension verification. The affected units were released without confirmation that belt tension met the specified requirements, which could lead to unintended downward movement of the table column. Unintended downward movement of the surgical table could occur, potentially resulting in disruption of patient positioning, reduced perfusion or oxygenation, musculoskeletal injury and/or interruption of a surgical procedure. To date, Baxter has not received any reports of patient injury related to this issue. Baxter will call to schedule a time to come in and perform the belt tension verification. Customers can continue to use the tables.

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
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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.