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U.S. Department of Health and Human Services

Class 2 Device Recall S83t Micomulti TEE

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  Class 2 Device Recall S83t Micomulti TEE see related information
Date Initiated by Firm August 30, 2019
Create Date May 01, 2020
Recall Status1 Open3, Classified
Recall Number Z-1844-2020
Recall Event ID 84902
510(K)Number K030455  
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
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
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
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = ITX and Original Applicant = PHILIPS ULTRASOUND, INC.
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