FDA Enforcement
Class II
Terminated
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 echocardiography (TEE) studies
Recall: Z-1843-2020
·
Reported May 13, 2020
Enforcement
- Recall Number
- Z-1843-2020
- Event ID
- 84902
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Ultrasound Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 13, 2020
- Initiation Date
- August 30, 2019
- Classification Date
- May 1, 2020
- Termination Date
- November 27, 2024
- Address
- 22100 Bothell Everett Hwy, N/A, Bothell, WA, 98021-8431, United States
Description
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 echocardiography (TEE) studies
Reason
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
Code Info
All lots.
Distribution
Worldwide distribution - US Nationwide distribution.
Quantity
N/A