FDA Medical devices recall ·
Philips 3D9-3v Transducer recall
- Recall number
- Z-2048-2025
- Date
- (initiated May 28, 2025)
- Company / brand
- Philips Ultrasound, Inc
1 Echo Dr, Reedsville, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5,230 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Philips 3D9-3v Transducer.
Why was it recalled?
Ultrasound transducer devices were refurbished beyond their useful life.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. 989605395622, 989605415032, 989605440832, 989605440831, 989605395622 , 989605325181; UDI: (01)00884838061545(21)B0D9FJ, (01)00884838061545(21)B10HWZ, (01)00884838061545(21)B1CQY1, (01)00884838061453(21)B13DR6, (01)00884838061545(21)B1C54Z, (01)00884838061545(21)B1MKLW, (01)00884838061545(21)B1MQGQ, (01)00884838061545(21)B1KWYY, (01)00884838061545(21)B1712M, (01)00884838061545(21)B1M9ZT, (01)00884838061545(21)B1DTRL, (01)00884838061545(21)B1K7BL, (01)00884838061545(21)B1RY9G, (01)00884838061453(21)B0T4K5, (01)00884838061545(21)B0T4K9, (01)00884838061545(21)B0TVWK, (01)00884838061545(21)B0PV0C, (01)00884838061545(21)B1301P, (01)00884838061545(21)B1MQGL, (01)00884838067707(21)036WF9, (01)00884838061545(21)B1LY5T, (01)00884838061545(21)B15F9B, (01)00884838061545(21)B15M6F, (01)00884838061545(21)B0X3K9, (01)00884838061453(21)B0LFYH, (01)00884838061453(21)B0LG5D, (01)00884838061545(21)B1TJB5, (01)00884838061545(21)B18NV8, (01)00884838061545(21)B1F54X, (01)00884838067707(21)B1LY5X, (01)00884838061545(21)B1VR93, (01)00884838061453(21)B0KH69, (01)00884838061545(21)B1VPLF, (01)00884838061545(21)B2BMFY, (01)00884838061545(21)B0R10J, (01)00884838061545(21)B14W77, (01)00884838061545(21)B176PT, (01)00884838061453(21)B0NFZD, (01)00884838061545(21)B0T4K4, (01)00884838061545(21)B0J7V5, (01)00884838061545(21)B0R15J, (01)00884838061545(21)B1GJ9L, (01)00884838061545(21)B0WH4P, (01)00884838061453(21)B0LWCV, (01)00884838067707(21)03BMY9, (01)00884838067707(21)B05DJQ, (01)00884838067707(2
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2048-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.