Class 2 Device Recall X51

• Date Initiated by Firm: May 28, 2025
• Date Posted: July 02, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2064-2025
• Recall Event ID: 96994
• 510(K)Number: K132304 K160807 K163120 K172607 K181485
• Product Classification: Transducer, ultrasonic, diagnostic - Product Code ITX
• Product: Philips X5-1 Transducer.
• Code Information: Model No. 989605400802; UDI: (01)00884838061422(21)B2XMDQ, (01)00884838061422(21)B3H27D, (01)00884838061422(21)B2ZXZB, (01)00884838061422(21)B26JC4, (01)00884838061422(21)B3GYXN, (01)00884838061422(21)B2ZXD8, (01)00884838061422(21)B3GJB2, (01)00884838061422(21)B2MQZ3, (01)00884838061422(21)B3L198, (01)00884838061422(21)B3KC2D, (01)00884838061422(21)B3MTN1, (01)00884838061422(21)B2894C; Serial No. B2XMDQ, B3H27D, B2ZXZB, B26JC4, B3GYXN, B2ZXD8, B1CGYC, B3GJB2, B2MQZ3, B3L198, B3KC2D, B3MTN1, B2894C, B1FHTZ.
• Recalling Firm/ Manufacturer: Philips Ultrasound, Inc; 1 Echo Dr; Reedsville PA 17084-8603
• For Additional Information Contact: Philips Customer Care Solutions Center; 1-800-722-9377
• Manufacturer Reason for Recall: Ultrasound transducer devices were refurbished beyond their useful life.
• FDA Determined Cause: Process control
• Action: An URGENT Medical Device Recall notification dated 5/28/25 was mailed to consignees. The notification informs consignees that Philips Ultrasound will be replacing transducers that were refurbished beyond their useful life with a new transducer. Consignees may continue to use affected devices while awaiting replacement; consignees should use devices in accordance with their intended use and per the instructions provided int he User Manual. Users should perform visual inspection and electrical safety testing as indicated in the User Manual; if a device does not pass inspection, it should be removed from clinical use. Consignees are asked to return the completed Response Form and circulate the provided notification to all users to ensure awareness. A copy of the recall notification should be kept with affected transducers until their replacement. Consignees with any questions can contact the Customer Care Solutions Center at 1-800-722-9377. Additional consignees were identified and notified via URGENT Medical Device Recall Notification on 9/5/25.
• Quantity in Commerce: 5,230 units
• Distribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.
• 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; 510(K)s with Product Code = ITX