PST 500 U Precision Surgical Table
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
---|---|---|
PST 500 U Precision Surgical Table |
109148151 |
4080300 |
Issue
Baxter Corporation is issuing an urgent medical device correction for the device 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.
A sudden drop and/or tilt of the surgical tabletop during a surgical procedure may cause unintended patient movement or fall. This could lead to delay or interruption in therapy, ineffective CPR, and could cause critical patient harm such as major musculoskeletal or vital organ injuries. Baxter has received six complaints related to this issue; however, no serious injury was reported.
Baxter will correct this issue by providing a service kit that can be installed either by a hospital technician or by a Baxter technician or authorized representative. If the service kit is self-installed, a Baxter technician or authorized representative will follow up to verify proper installation.
Recall start date: July 2, 2024
Additional information
Details
Baxter Medical Systems GmbH T Co. KG
Karl-Zeiss-Str. 7-9, Saalfeld, Germany, 07318
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