Baxter Precision Surgical Table Recall: Loose Spring Pins Risk
Baxter Healthcare Corporation is recalling the PST 500 U Precision Surgical Table due to loose spring pins that can cause the tabletop to unexpectedly tilt or move, potentially causing unintended patient movement during surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a medical device with a mechanical failure that poses a credible risk of patient harm through unexpected movement during surgery. Although no illnesses or injuries have been reported, the hazard affects surgical equipment in active use on patients, making this a risk-of-harm situation that warrants a High severity rating.
Plain-English summary
Baxter Healthcare Corporation is issuing an urgent correction for the PST 500 U Precision Surgical Table due to a potential issue with loose spring pins in the spindle drives.
The loose spring pins can cause the surgical table's tabletop to unexpectedly tilt or move without warning, even when the table is not in active use.
This defect could result in unintentional patient movement during or in preparation for surgical procedures, as well as during transport of the surgical table, potentially causing patient harm.
Approximately 400 units are affected by this correction and have been distributed worldwide, including throughout the US and Canada. Healthcare facilities using this equipment should contact Baxter Healthcare Corporation immediately for instructions on addressing this issue.
The recalled product
- Product
- Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- loose-spring-pins
- unexpected-movement
- patient-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 00887761973671
- Serial Numbers: 107936298
- 107936299
- 107936300
- 107946575
- 107946576
- 107949857
- 107951075
- 107952514
- 107954982
- 108021169
- 108023287
- 108028575
- 108028716
- 108028747
- 108028798
- 108028801
- 108028803
- 108028817
- 108028829
Distribution
Distributed nationwide across the United States.
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