Product Safety Recalls

Product Recall Tracker

Philips Ultrasound Inc Recall 88514

Description: Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119

Philips Ultrasound Inc Recall 88514 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2484-2021
Event ID88514
Event DescriptionAffiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119
Product TypeDevices
DistributionWorldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Albania, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Brazil, Brunei Darussalam, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Germany, Gibraltar, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, State of Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam, Virgin Island, Yemen and Zambia.
QuantityTotal = 10,583 systems (EPIQ and Afiniti)
Recall ReasonDue to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
Device Classification20210929
Device Code InfoAfiniti Diagnostic Ultrasound Systems: Affiniti 30 Model Number: 795121 Serial Numbers/UDI Codes US219E1452 (01)00884838074187(21)US219E1452 US220E0262 (01)00884838074187(21)US220E0262 US320E1098 (01)00884838074187(21)US320E1098 US320E1099 (01)00884838074187(21)US320E1099 US918E0145 (01)00884838074187(21)US918E0145 USN18E0607 (01)00884838074187(21)USN18E0607 USN18E1617 (01)00884838074187(21)USN18E1617 USN19E2219 (01)00884838074187(21)USN19E2219 USN19E2220 (01)00884838074187(21)USN19E2220 USN19E2221 (01)00884838074187(21)USN19E2221 Affiniti 30 Model Number: 795218 Serial Numbers/UDI Codes PU220E1330 N/A PU220E1331 N/A PU220E1332 N/A PU220E1333 N/A PU220E1334 N/A PU220E1335 N/A PU420E0442 N/A PU420E0658 N/A PU420E0659 N/A PU420E0660 (01)00884838097957 PU420E0761 (01)00884838074187 PU520E0703 (01)00884838074187 PU520E0713 N/A PU520E0854 (01)00884838074187 PU520E0855 N/A PU520E0856 N/A PU520E0857 N/A PU520E0858 N/A PU520E0859 N/A PU520E0861 N/A PU520E0965 N/A PU520E0966 N/A 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Center Classification Date20210917
Recall Initiation Date20210806
Termination Date)USO19E2552 USO19E2615 (01)00884838074187(21)USO19E2615 USO19E2616 (01)00884838074187(21)USO19E2616 USO19E2624 (01)00884838074187(21)USO19E2624 USO19E2628 (01)00884838074187(21)USO19E2628 USO19E2629 (01)00884838074187(21)USO19E2629 USO19E2630 (01)00884838074187(21)USO19E2630 USO19E2631 (01)00884838074187(21)USO19E2631 USO19E2632 (01)00884838074187(21)USO19E2632 USO19E2770 (01)00884838074187(21)USO19E2770 USO19E2775 (01)00884838074187(21)USO19E2775 USO19E2776 (01)00884838074187(21)USO19E2776 USO19E2777 (01)00884838074187(21)USO19E2777 USO19E2778 (01)00884838074187(21)USO19E2778 USO19E2779 (01)00884838074187(21)USO19E2779 USO19E2782 (01)00884838074187(21)USO19E2782 USO19E2783 (01)00884838074187(21)USO19E2783 USO19E2868 (01)00884838074187(21)USO19E2868 USO19E2869 (01)00884838074187(21)USO19E2869 USO19E2909 (01)00884838074187(21)USO19E2909 USO20E1064 (01)00884838074187(21)USO20E1064 Affiniti 50 Model Number: 795208 Serial Numbers/UDI Codes BZ120D0069 N/A BZ120D0177 N/A 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(01)00884838056244(21)USN19D0860 USN19D0863 (01)00884838056244(21)USN19D0863 USN19D0864 (01)00884838056244(21)USN19D0864 USN19D0889 (01)00884838056244(21)USN19D0889 USN19D0890 (01)00884838056244(21)USN19D0890 USN19D0891 (01)00884838056244(21)USN19D0891 USN19D0892 (01)00884838056244(21)USN19D0892 USN19D0893 (01)00884838056244(21)USN19D0893 USN19D0894 (01)00884838056244(21)USN19D0894 USN19D0895 (01)00884838056244(21)USN19D0895 USN19D0896 (01)00884838056244(21)USN19D0896 USN19D1119 (01)00884838056244(21)USN19D1119 USN19D1120 (01)00884838056244(21)USN19D1120 USN19D1121 (01)00884838056244(21)USN19D1121 USN19D1122 (01)00884838056244(21)USN19D1122 USN19D1123 (01)00884838056244(21)USN19D1123 USN19D1174 (01)00884838056244(21)USN19D1174 USN19D1175 (01)00884838056244(21)USN19D1175 USN19D1254 (01)00884838056244(21)USN19D1254 USN19D1255 (01)00884838056244(21)USN19D1255 USN19D1256 (01)00884838056244(21)USN19D1256 USN19D1257 (01)00884838056244(21)USN19D1257 USN19D1258 (01)00884838056244(21)USN19D1258 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(01)00884838056244(21)USO19D0418 USO19D0582 (01)00884838056244(21)USO19D0582 USO19D0583 (01)00884838056244(21)USO19D0583 USO19D0584 (01)00884838056244(21)USO19D0584 USO19D0585 (01)00884838056244(21)USO19D0585 USO19D0586 (01)00884838056244(21)USO19D0586 USO19D0811 (01)00884838056244(21)USO19D0811 USO19D0812 (01)00884838056244(21)USO19D0812 USO19D0815 (01)00884838056244(21)USO19D0815 USO19D0912 (01)00884838056244(21)USO19D0912 USO19D0935 (01)00884838056244(21)USO19D0935 USO19D1582 (01)00884838056244(21)USO19D1582 USO19D1585 (01)00884838056244(21)USO19D1585 USO19D1586 (01)00884838056244(21)USO19D1586 USO19D1599 (01)00884838056244(21)USO19D1599 USO19D1600 (01)00884838056244(21)USO19D1600 USO19D1667 (01)00884838056244(21)USO19D1667 USO19D1668 (01)00884838056244(21)USO19D1668 USO19D1669 (01)00884838056244(21)USO19D1669 USO19D1705 (01)00884838056244(21)USO19D1705 USO19D1706 (01)00884838056244(21)USO19D1706 USO19D1707 (01)00884838056244(21)USO19D1707 USO19D1726 (01)00884838056244(21)USO19D1726 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(01)00884838056244(21)USO19D2377 USO19D2378 (01)00884838056244(21)USO19D2378 USO19D2505 (01)00884838056244(21)USO19D2505 USO19D2506 (01)00884838056244(21)USO19D2506 USO19D2547 (01)00884838056244(21)USO19D2547 USO19D2548 (01)00884838056244(21)USO19D2548 USO19D2549 (01)00884838056244(21)USO19D2549 USO19D2550 (01)00884838056244(21)USO19D2550 USO19D2621 (01)00884838056244(21)USO19D2621 USO19D2622 (01)00884838056244(21)USO19D2622 USO19D2623 (01)00884838056244(21)USO19D2623 USO19D2766 (01)00884838056244(21)USO19D2766 USO19D2767 (01)00884838056244(21)USO19D2767 USO19D2799 (01)00884838056244(21)USO19D2799 USO19D2867 (01)00884838056244(21)USO19D2867 USO19D2913 (01)00884838056244(21)USO19D2913 USO19D2914 (01)00884838056244(21)USO19D2914 USO19D2915 (01)00884838056244(21)USO19D2915 USO20D2118 (01)00884838056244(21)USO20D2118 Affiniti 50 Model Number: 795118 Serial Numbers/UDI Codes US319D0387 (01)00884838056244(21)US319D0387 US519D1329 (01)00884838056244(21)US519D1329 USN18D0258 (01)00884838056244(21)USN18D0258 USN18D1294 (01)00884838056244(21)USN18D1294 USN19D0472 (01)00884838056244(21)USN19D0472 USN19D0777 (01)00884838056244(21)USN19D0777 USO19D0318 (01)00884838056244(21)USO19D0318 USO19D0569 (01)00884838056244(21)USO19D0569 Affiniti 70 Model Number: 795210 Serial Numbers/UDI Codes BZ119F0375 N/A BZ119F0864 N/A BZ120F0638 N/A BZ120F0867 N/A BZ120F0868 N/A BZ120F0911 N/A BZ120F0913 N/A BZ120F0989 N/A BZ120F0990 N/A BZ120F1061 N/A BZ120F1078 N/A BZ120F1081 N/A BZ120F1154 N/A BZ120F1155 N/A BZ120F1157 N/A BZ120F1209 N/A BZ120F1212 N/A BZ120F1213 N/A BZ120F1284 N/A BZ120F1895 N/A BZ120F1948 (01)00884838056251 BZ120F2068 (01)00884838056251 BZ218F1111 (01)00884838056251 BZ220F1621 N/A BZ220F1622 N/A BZ318F1335 N/A BZ320F0234 N/A BZ320F1758 N/A BZ320F1759 N/A BZ320F1990 N/A BZ416F0036 N/A BZ420F0123 N/A BZ420F0124 N/A BZ720F1656 (01)00884838097766 BZ720F1658 (01)00884838056251 BZ720F1659 N/A BZ720F1660 N/A BZ720F1662 N/A BZ720F1663 N/A BZ720F1664 (01)00884838056251 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(01)00884838056251(21)USO19F1992 USO19F1993 (01)00884838056251(21)USO19F1993 USO19F1994 (01)00884838056251(21)USO19F1994 USO19F1995 (01)00884838056251(21)USO19F1995 USO19F1996 (01)00884838056251(21)USO19F1996 USO19F1997 (01)00884838056251(21)USO19F1997 USO19F1998 (01)00884838056251(21)USO19F1998 USO19F1999 (01)00884838056251(21)USO19F1999 USO19F2017 (01)00884838056251(21)USO19F2017 USO19F2018 (01)00884838056251(21)USO19F2018 USO19F2019 (01)00884838056251(21)USO19F2019 USO19F2020 (01)00884838056251(21)USO19F2020 USO19F2021 (01)00884838056251(21)USO19F2021 USO19F2022 (01)00884838056251(21)USO19F2022 USO19F2023 (01)00884838056251(21)USO19F2023 USO19F2033 (01)00884838056251(21)USO19F2033 USO19F2034 (01)00884838056251(21)USO19F2034 USO19F2035 (01)00884838056251(21)USO19F2035 USO19F2036 (01)00884838056251(21)USO19F2036 USO19F2073 (01)00884838056251(21)USO19F2073 USO19F2075 (01)00884838056251(21)USO19F2075 USO19F2121 (01)00884838056251(21)USO19F2121 USO19F2123 (01)00884838056251(21)USO19F2123 USO19F2124 (01)00884838056251(21)USO19F2124 USO19F2125 (01)00884838056251(21)USO19F2125 USO19F2126 (01)00884838056251(21)USO19F2126 USO19F2127 (01)00884838056251(21)USO19F2127 USO19F2154 (01)00884838056251(21)USO19F2154 USO19F2200 (01)00884838056251(21)USO19F2200 USO19F2201 (01)00884838056251(21)USO19F2201 USO19F2202 (01)00884838056251(21)USO19F2202 USO19F2203 (01)00884838056251(21)USO19F2203 USO19F2204 (01)00884838056251(21)USO19F2204 USO19F2205 (01)00884838056251(21)USO19F2205 USO19F2303 (01)00884838056251(21)USO19F2303 USO19F2356 (01)00884838056251(21)USO19F2356 USO19F2379 (01)00884838056251(21)USO19F2379 USO19F2380 (01)00884838056251(21)USO19F2380 USO19F2381 (01)00884838056251(21)USO19F2381 USO19F2382 (01)00884838056251(21)USO19F2382 USO19F2383 (01)00884838056251(21)USO19F2383 USO19F2409 (01)00884838056251(21)USO19F2409 USO19F2410 (01)00884838056251(21)USO19F2410 USO19F2411 (01)00884838056251(21)USO19F2411 USO19F2412 (01)00884838056251(21)USO19F2412 USO19F2415 (01)00884838056251(21)USO19F2415 USO19F2416 (01)00884838056251(21)USO19F2416 USO19F2496 (01)00884838056251(21)USO19F2496 USO19F2497 (01)00884838056251(21)USO19F2497 USO19F2499 (01)00884838056251(21)USO19F2499 USO19F2501 (01)00884838056251(21)USO19F2501 USO19F2502 (01)00884838056251(21)USO19F2502 USO19F2503 (01)00884838056251(21)USO19F2503 USO19F2504 (01)00884838056251(21)USO19F2504 USO19F2545 (01)00884838056251(21)USO19F2545 USO19F2546 (01)00884838056251(21)USO19F2546 USO19F2586 (01)00884838056251(21)USO19F2586 USO19F2587 (01)00884838056251(21)USO19F2587 USO19F2588 (01)00884838056251(21)USO19F2588 USO19F2617 (01)00884838056251(21)USO19F2617 USO19F2618 (01)00884838056251(21)USO19F2618 USO19F2619 (01)00884838056251(21)USO19F2619 USO19F2620 (01)00884838056251(21)USO19F2620 USO19F2689 (01)00884838056251(21)USO19F2689 USO19F2763 (01)00884838056251(21)USO19F2763 USO19F2764 (01)00884838056251(21)USO19F2764 USO19F2765 (01)00884838056251(21)USO19F2765 USO19F2768 (01)00884838056251(21)USO19F2768 USO19F2769 (01)00884838056251(21)USO19F2769 USO19F2784 (01)00884838056251(21)USO19F2784 USO19F2785 (01)00884838056251(21)USO19F2785 USO19F2786 (01)00884838056251(21)USO19F2786 USO19F2787 (01)00884838056251(21)USO19F2787 USO19F2788 (01)00884838056251(21)USO19F2788 USO19F2789 (01)00884838056251(21)USO19F2789 USO19F2790 (01)00884838056251(21)USO19F2790 USO19F2791 (01)00884838056251(21)USO19F2791 USO19F2792 (01)00884838056251(21)USO19F2792 USO19F2793 (01)00884838056251(21)USO19F2793 USO19F2794 (01)00884838056251(21)USO19F2794 USO19F2795 (01)00884838056251(21)USO19F2795 USO19F2796 (01)00884838056251(21)USO19F2796 USO19F2797 (01)00884838056251(21)USO19F2797 USO19F2798 (01)00884838056251(21)USO19F2798 USO19F2916 (01)00884838056251(21)USO19F2916 USO19F2917 (01)00884838056251(21)USO19F2917 USO19F2918 (01)00884838056251(21)USO19F2918 USO19F2919 (01)00884838056251(21)USO19F2919 USO19F2920 (01)00884838056251(21)USO19F2920 USO19F2921 (01)00884838056251(21)USO19F2921 USO19F2924 (01)00884838056251(21)USO19F2924 USO19F2925 (01)00884838056251(21)USO19F2925 USO20F1789 (01)00884838056251(21)USO20F1789 Affiniti 70 Model Number: 795119 Serial Numbers/UDI Codes US120F1622 (01)00884838056251(21)US120F1622 US215F0692 N/A US414F0194 N/A US419F0618 (01)00884838056251(21)US419F0618 US514F0204 N/A US519F0207 (01)00884838056251(21)US519F0207 US714F0716 N/A US719F1248 (01)00884838056251(21)US719F1248 US720F1570 (01)00884838056251(21)US720F1570 US720F1571 (01)00884838056251(21)US720F1571 US720F1572 (01)00884838056251(21)US720F1572 US720F1573 (01)00884838056251(21)US720F1573 US720F1574 (01)00884838056251(21)US720F1574 US814F0056 N/A US918F1096 (01)00884838056251(21)US918F1096 USD20F1270 ( 01)00884838056251(21)USD20F1270 USO18F2086 (01)00884838056251(21)USO18F2086 USO19F0187 (01)00884838056251(21)USO19F0187 USO19F0188 (01)00884838056251(21)USO19F0188 USO19F0189 (01)00884838056251(21)USO19F0189 USO19F1915 (01)00884838056251(21)USO19F1915
Recalling FirmPhilips Ultrasound Inc
Initial Notification Letter
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