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Parker Quality & Compliance

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Device recall

Operating Table TruSystem 7000 U (dV), Model/Catalog Number: 1723633

FDA recall source

Recall number
Z-0353-2027
Event id
100117
Status
Open, Classified
FDA classification
Class I
Recalling firm
Baxter Healthcare Corporation
Posted
Nov 3, 2026
Initiated
Sep 29, 2026
Product code
GDC
Device type
Table, Operating-Room, Electrical
Reason
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.
Root cause
Nonconforming Material/Component
Quantity
62 units
Code info
Serial numbers: 108920104, 110192607, 110192885, 110208936, 110212885, 110220066, 110227520, 110248337, 110250614, 109423464, 110192608, 110192886, 110208941, 110212886, 110220068, 110227523, 110248343, 110250621, 109517138, 110192609, 110206656, 110210717, 110220055, 110220069, 110227524, 110249706, 110250622, 110139767, 110192683, 110206657, 110210718, 110220056, 110220071, 110227525, 110249712, 110206662, 110139776, 110192882, 110206659, 110210720, 110220057, 110220072, 110227552, 110250605, 110188921, 110188919, 110192883, 110206660, 110210721, 110220058, 110220078, 110227553, 110250609, 110188922, 110188920, 110192884, 110206664, 110212881, 110220065, 110220079, 110248218, 110250613; UDI-DI number: 00887761967519
Distribution
Worldwide - US Nationwide distribution.
Location
Deerfield, IL