Recall Z-1841-2020— Philips Ultrasound Inc
Class II · Terminated
Class II FDA medical device recall by Philips Ultrasound Inc, initiated 2019-08-30, terminated 2024-11-27. It names 2 FDA 510(k) clearances: K162329, K160807. 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 (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.
- Recalling firm
- Philips Ultrasound Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-30
- Terminated
- 2024-11-27
- Firm location
- Bothell, WA, United States
510(k) clearances named in this recall
2 on FDA's record- K162329 — CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System
- K160807 — EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 (TEE) studies
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.