Home / Recalls / Philips Ultrasound Inc / Z-2484-2021

Z-2484-2021 Class II

Recalled by Philips Ultrasound Inc — Bothell, WA

FDA device recall Z-2484-2021 was initiated by Philips Ultrasound Inc on August 6, 2021 and is designated Class II. 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. Affected quantity: Total = 10,583 systems (EPIQ and Afiniti).

Recall Details

Product Type
Devices
Report Date
September 29, 2021
Initiation Date
August 6, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Total = 10,583 systems (EPIQ and Afiniti)

Product 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

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 Pattern

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, 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.

Code Information

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 PU820E0349 N/A PU820E0525 N/A PU820E0526 N/A PU820E0535 N/A PU820E0536 N/A PU820E0540 N/A PU820E0541 N/A PU820E0544 (01)00884838074187 PU820E0545 N/A PU820E0654 (01)00884838074187 PUD19E0772 N/A PUD19E0832 N/A PUD19E0833 N/A US117E1004 (01)00884838074187(21)US117E1004 US118E1385 (01)00884838074187(21)US118E1385 US119E0798 (01)00884838074187(21)US119E0798 US119E0912 (01)00884838074187(21)US119E0912 US119E1661 (01)00884838074187(21)US119E1661 US119E1662 (01)00884838074187(21)US119E1662 US120E0309 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Other recalls by Philips Ultrasound Inc

  • Z-0883-2026 Class II — Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841, (October 31, 2025)
  • Z-1621-2026 Class III — Philips L17-5 Ultrasound Transducer (September 5, 2025)
  • Z-1625-2026 Class III — Philips S4-1 Ultrasound Transducer (September 5, 2025)
  • Z-1619-2026 Class III — Philips C9-4 Ultrasound Transducer (September 5, 2025)
  • Z-1626-2026 Class III — Philips S5-2 Ultrasound Transducer (September 5, 2025)
  • Z-1622-2026 Class III — Philips Mini Multi TEE Ultrasound Transducer (September 5, 2025)
  • Z-1627-2026 Class III — Philips X3-1 Ultrasound Transducer (September 5, 2025)
  • Z-1618-2026 Class III — Philips 3D6-2 Ultrasound Transducer (September 5, 2025)
  • Z-1620-2026 Class III — Philips L12-5 Ultrasound Transducer (September 5, 2025)
  • Z-1624-2026 Class III — Philips OMNI III TEE Ultrasound Transducer (September 5, 2025)

FDA data resources