Baxter Healthcare Corporation: Device Recall

Recall #Z-2512-2024 · 06/28/2024

Class II: Risk

Recall Details

Recall Number
Z-2512-2024
Classification
Class II
Product Type
Device
Recalling Firm
Baxter Healthcare Corporation
Status
Ongoing
Date Initiated
06/28/2024
Location
Deerfield, IL, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
400 units

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.

Product Description

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

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.