FDA recall Z-2512-2024

Baxter Healthcare Corporation · Class II · device

Product

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

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.

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status
Ongoing
Initiation date
2024-06-28
Report date
2024-08-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2512-2024