Z-2065-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 9, 2025
- Initiation Date
- May 28, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,230 units
Product Description
Philips X6-1 Transducer.
Reason for Recall
Ultrasound transducer devices were refurbished beyond their useful life.
Distribution Pattern
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.
Code Information
Model No. 989605409282, 989605438511, 989605357143, 989605357141; UDI: (01)00884838061446(21)B1HT1C, (01)00884838061446(21)B1HT47, (01)00884838061446(21)B1W368, (01)00884838061446(21)B1WBDL, (01)00884838061446(21)B1GTFL, (01)00884838061446(21)B11YW3, (01)00884838061446(21)B15QX1, (01)00884838061446(21)B14LVN, (01)00884838061446(21)B22R48, (01)00884838061446(21)B11XQP, (01)00884838061446(21)B1HTJ3, (01)00884838061446(21)B11Z3B, (01)00884838061446(21)B0WX2W, (01)00884838061446(21)B0WYZ1, (01)00884838061446(21)B131LH, (01)00884838061446(21)B1C1C3, (01)00884838061446(21)B1JBBF, (01)00884838061446(21)B101WK, (01)00884838061446(21)B14M20, (01)00884838061446(21)B1GVWH, (01)00884838061446(21)B1H6V3, (01)00884838061446(21)B101TF, (01)00884838061446(21)B1JCYV, (01)00884838061446(21)B2HQD0, (01)00884838061446(21)B27YP9, (01)00884838061446(21)B21DZ3, (01)00884838061446(21)B0Z7G7, (01)00884838061446(21)B0V082, (01)00884838061446(21)B22QVL, (01)00884838061446(21)B14MMW, (01)00884838061446(21)B24VGG, (01)00884838061446(21)B21CGY, (01)00884838061446(21)B1GTDB, (01)00884838061781(21)B157R5, (01)00884838061781(21)B1903C, (01)00884838061781(21)B187M7, (01)00884838061446(21)B21CH0, (01)00884838061781(21)B14MMX, (01)00884838061446(21)B2HQCW, (01)00884838061446(21)B18YDK, (01)00884838061781(21)B13R4G, (01)00884838061781(21)B11X02, (01)00884838061446(21)B18Z17, (01)00884838061446(21)B0V150, 010088483806144621B1WQHH; Serial No. B1HT1C, B1HT47, B1W368, B1WBDL, B1GTFL, B11YW3, B15QX1, B14LVN, B22R48, B11XQP, B1HTJ3, B11Z3B, B0WX2W, B0WYZ1, B131LH, B1C1C3, B1JBBF, B14P5W, B101WK, B14M20, B1GVWH, B1H6V3, B101TF, B1JCYV, B2HQD0, B27YP9, B21DZ3, B0Z7G7, B0V082, B22QVL, B132FF, B14MMW, B19075, B24VGG, B21CGY, B1GTDB, B157R5, B1903C, B1HTQB, B187M7, B0TZQM, B21CH0, B14MMX, B0Z7GF, B06HHH, B2HQCW, B18YDK, B13R4G, B131XX, B0WYDD, B0WYNP, B11X02, B18Z17, B1H9YQ, B1H9YR, B0V150, B1WQHH.