The Recall Desk

FDA (Devices) recall action 84902

Philips Ultrasound Inc recalled 4 products on 2020-05-13

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2020-05-13
Critical
0
Units
—

Why these products were recalled

The firm has discovered an issue associated with some Transesophageal (TEE) transducers that 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 result in affected transducers not initiating auto-cool during use which could result in patient injury

The agency’s own wording, quoted from the enforcement report.

1–4 of 4

  • SevereFDA (Devices)··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.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-05-13

    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.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-05-13

    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.

    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 (
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··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.

    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 echocard
    Category
    Distribution
    0 states