Agency classClass IIOur severity:Severe FDA (Devices)·Z-1842-2020·Announced 2020-05-13

Philips Recalls Transesophageal Ultrasound Transducers Due to Temperature Measurement Defect

Philips Ultrasound Inc is recalling S7-3t transesophageal transducers because a programming error prevents the system from measuring tip temperature, which may stop auto-cooling and cause 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 agency classification is Class II, and the source text explicitly states the defect 'could result in patient injury,' which aligns with the rubric criterion for significant injury reports or high-risk medical device defects.

Plain-English summary

Philips Ultrasound Inc is recalling specific S7-3t transesophageal (TEE) ultrasound transducers. These devices are used as accessories with iE33 and HD11 ultrasound systems for diagnostic imaging and fluid flow analysis, particularly for transesophageal echocardiography (TEE) studies. The affected transducers have the UDI (01)00884838067530 and REF 989605439232. The recall covers all lots and includes units distributed worldwide and nationwide in the US.

The recall is being issued because some of these transducers were not properly programmed during manufacturing. As a result, the ultrasound system is unable to correctly measure the temperature at the distal tip of the transducer. This defect may prevent the device from initiating its auto-cool function during use, which could result in patient injury.

Healthcare facilities and users should stop using the affected transducers immediately. Users should contact Philips Ultrasound Inc for instructions on how to return or replace the devices. The source text does not specify a number of affected units or report any specific injuries to date.

The recalled product

Product: Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies
Manufacturer: Philips Ultrasound Inc
Category: Medical Device — Ultrasound Transducer
Hazard: burn-injury
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