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
Check against the official notice below — it lists the full affected range.
Philips Ultrasound Inc. is recalling Affiniti Diagnostic Ultrasound Systems in software versions 5.0, 5.0.1, and 5.0.2 across multiple model numbers (Affiniti 30 and Affiniti 50). The systems are affected by a software defect that can intermittently cause the system to lock up when exiting Review Mode during an exam. A total of 10,583 systems have been distributed worldwide, including throughout all U.S. states, Puerto Rico, and numerous international locations.
The recall affects specific serial numbers of the affected models. According to the recall record provided, no remedy has been specified for consumers to address this issue.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
Reason for recall: Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam. Distribution: Worldwide 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, Belg Quantity: Total = 10,583 systems (EPIQ and Afiniti) Lot/code info: Afiniti 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 PU520E0967 N/A PU520E0968 N/A PU520E1012 N/A PU520E1013 (01)00884838074187 PU520E1014 (01)00884838074187 PU520E1015 N/A PU520E1016 N/A PU520E1017 (01)00884838074187 PU520E2820 (01)00884838097957 PU520E2821 (01)00884838097957 PU520E2831 (01)00884838097957 PU620E0090 (01)00884838097957 PU720E0464 (01)00884838074187 PU720E0468 N/A PU720E0611 (01)00884838097957 PU720E0800 (01)00884838097957 PU720E0801 (01)00884838097957 PU720E0803 N/A PU720E0804 N/A PU820E0248 N/A PU820E0249 N/A PU820E0347 (01)00884838097957 PU820
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.