Date Initiated by Firm | August 30, 2019 |
Create Date | May 01, 2020 |
Recall Status1 |
Terminated 3 on November 27, 2024 |
Recall Number | Z-1843-2020 |
Recall Event ID |
84902 |
510(K)Number | K172607 |
Product Classification |
Transducer, ultrasonic, diagnostic - Product Code ITX
|
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 echocardiography (TEE) studies |
Code Information |
All lots. |
Recalling Firm/ Manufacturer |
Philips Ultrasound Inc 22100 Bothell Everett Hwy Bothell WA 98021-8431
|
For Additional Information Contact | 800-722-9377 |
Manufacturer 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 |
FDA Determined Cause 2 | Process control |
Action | If you have an EPIQ, Affiniti or iE33 system, verify that all your S7-3t and S8-3t TEE transducers are programmed properly by connecting them to the system, checking the transducer temperature (TEE T) on the display, and following the instructions provided on this letter.
If you determine that your transducer is not properly programmed, discontinue using the transducer immediately and contact your local Philips representative to schedule an appointment with a field service engineer.
If you have an HD11 or CX50 system discontinue using the S7-3t and S8-3t transducer immediately and contact your local Philips representative for support.
Please complete the included reply form on the last page and return to Philips as soon as possible via email to ultrasound.corrections@philips.com, or fax to 1-833-512-7756. |
Distribution | Worldwide distribution - US Nationwide distribution. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = ITX
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