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U.S. Department of Health and Human Services

Class 2 Device Recall S73t PUC

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 Class 2 Device Recall S73t PUCsee related information
Date Initiated by FirmAugust 30, 2019
Create DateMay 01, 2020
Recall Status1 Completed
Recall NumberZ-1842-2020
Recall Event ID 84902
510(K)NumberK030455 K043535 
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
ProductTransducer 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
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
ActionIf 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.
DistributionWorldwide distribution - US Nationwide distribution.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = ITX
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