Philips S8-3t Transesophageal Ultrasound Transducers Recalled for Temperature Measurement Failure
Philips is recalling S8-3t transesophageal transducers that may fail to measure tip temperature correctly, potentially preventing auto-cooling and causing patient injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk-of-harm product where patient injury is possible due to a failure in a safety mechanism (auto-cool), but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Ultrasound Inc is recalling specific S8-3t transesophageal (TEE) transducers used with the iE33 Ultrasound System. The recall involves units that were not properly programmed during manufacturing, resulting in the system's inability to correctly measure the temperature at the distal tip of the transducer.
This defect may prevent the transducer from initiating its auto-cool function during use. The failure to activate auto-cooling could result in patient injury. The affected products were distributed worldwide and nationwide in the United States.
Healthcare facilities should stop using the affected transducers and contact Philips Ultrasound Inc for further instructions on the recall process.
The recalled product
- Product
- Transducer S8-3t UDI (01)00884838067523 REF 989605420183 Can be used with: iE33 Utrasound System - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies
- Manufacturer
- Philips Ultrasound Inc
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 (1)
- All lots.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Philips Ultrasound Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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