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 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
