Health product recall

PST 500 U Precision Surgical Table

Last updated

Summary

Product
PST 500 U Precision Surgical Table
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

PST 500 U Precision Surgical Table

109148151
108029053
108167723
108649034
108664873
109393980
109395301
108167561
108424302

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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies

Baxter Medical Systems GmbH T Co. KG

Karl-Zeiss-Str. 7-9, Saalfeld, Germany, 07318

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-75784

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