Philips Recalls Transesophageal Ultrasound Transducers Due to Temperature Measurement Failure
Philips Ultrasound Inc is recalling S7-3t transesophageal transducers because a manufacturing programming error prevents the system from correctly measuring tip temperature, which may stop auto-cooling and cause patient injury.
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: The recall involves a risk-of-harm product where patient injury is possible due to the failure of a safety mechanism (auto-cool), but the source text does not report any actual injuries or illnesses, meeting the criteria for a High severity score.
Plain-English summary
Philips Ultrasound Inc is recalling the S7-3t transesophageal (TEE) transducer, UDI (01)00884838061439, REF 989605406772. These devices are used with CX50, EPIQ 7, Affiniti 50, and Affiniti 70 ultrasound systems for diagnostic imaging and fluid flow analysis, particularly for transesophageal echocardiography (TEE) studies.
The recall was initiated because the firm discovered that some transducers were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of the transducer. This issue may prevent the transducers from initiating auto-cool during use, which could result in patient injury.
The recall covers all lots and includes worldwide and US nationwide distribution. The source text does not specify the number of affected units or report any specific injuries or illnesses. Users of these devices should contact Philips Ultrasound Inc for further instructions on how to proceed.
The recalled product
- Product
- Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti 70 Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (
- 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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