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U.S. Department of Health and Human Services

Class 3 Device Recall 7.5MHZ Endo Transducer

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 Class 3 Device Recall 7.5MHZ Endo Transducersee related information
Date Initiated by FirmJuly 03, 2025
Date PostedAugust 22, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2348-2025
Recall Event ID 97217
510(K)NumberK014191 K972348 K990339 
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product7.5MHZ Endo Transducer Probe
Code Information UDI: N/A; Serial No. F00262.
Recalling Firm/
Manufacturer		 Philips Ultrasound, Inc
1 Echo Dr
Reedsville PA 17084-8603
For Additional Information ContactPhilips Customer Care Solutions Center
1-800-722-9377
Manufacturer Reason
for Recall		To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
FDA Determined
Cause 2		Device Design
ActionAn URGENT Medical Device Correction Notice, dated 7/3/25, was mailed to consignees. This notice instructs consignees to locate all Philips Ultrasound transducers in their facility and enter their serial numbers into https://www.transducer.philips.com to obtain the manufacturing certificate for each of their devices. This certificate should be retained with its system documentation. Using the manufacturing certificate consignees are to calculate the useful life of their device. The expected useful life for Transesophageal transducers, X-Matrix transducers, and Lumify transducers is 5 years; The expected useful life for Endocavity transducers and Transcutaneous transducers is 7 years. If a transducer has exceeded its useful life, consignees are instructed to conduct transducer performance tests or contact Philips for guidance. Consignees are asked to complete and return the provided response form and circulate the recall notification to device users for their awareness. Consignees with any questions can contact Philips Customer Care Solutions Center at 1-800-722-9377.
Quantity in Commerce171,322 units
DistributionUS 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.
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) Database510(K)s with Product Code = ITX
510(K)s with Product Code = ITX
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