Agency classClass IIOur severity:Severe FDA (Devices)·Z-1843-2020·Announced 2020-05-13

Philips TEE Transducers Recalled Due to Temperature Measurement Failure

Philips Ultrasound Inc 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source explicitly states the defect 'could result in patient injury' and the agency classification is Class II, aligning with the rubric criterion for significant injury reports or risk-of-harm products.

Plain-English summary

Philips Ultrasound Inc is recalling S8-3t transesophageal (TEE) transducers, identified by UDI (01)00884838073524 and REF 989605431171. These devices are used as accessories with EPIQ 7, Affiniti 70, EPIQ 5, and EPIQ CVxi Ultrasound systems for diagnostic imaging and fluid flow analysis, particularly for transesophageal echocardiography (TEE) studies. The recall covers all lots and includes worldwide and US nationwide distribution.

The recall was initiated because some transducers were not properly programmed during manufacturing. This defect prevents the system from correctly measuring the temperature at the distal tip of the transducer. Consequently, affected transducers may not initiate the auto-cool function during use, which could result in patient injury.

Healthcare facilities and users 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)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal…
Manufacturer: Philips Ultrasound Inc
Category: Medical Device — Ultrasound Transducer
Hazard: burn-injury
device-malfunction

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.

See all 4 products in this recall →

Same manufacturer · Philips Ultrasound Inc

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Same hazard · burn injury