Class 2 Device Recall Philips Afiniti Diagnostic Ultrasound Systems

• Date Initiated by Firm: August 06, 2021
• Create Date: September 17, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2484-2021
• Recall Event ID: 88514
• 510(K)Number: K182857
• Product Classification: System, imaging, pulsed echo, ultrasonic - Product Code IYO
• Product: 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
• 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 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(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 Firm/ Manufacturer: Philips Ultrasound Inc; 22100 Bothell Everett Hwy; Bothell WA 98021-8431
• For Additional Information Contact: Holly Wright Lee; 440-483-2015
• Manufacturer 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.
• FDA Determined Cause: Software design
• Action: On 08/06/2021, the firm sent via certified mail an "URGENT Medical Device Correction" Notification Letter to customer informing them that due to a software defect, when reviewing or adjusting xPlane exam results, there is a potential for the ultrasound systems to become unresponsive (Lock-up) preventing users from continuing clinical use. The ultrasound system provides an error notification including method to restart and bring system back to normal use. The Recalling Firm has received a report of an ultrasound system locking up multiple times during an open cardiac procedure while using a Transesophageal Echocardiogram (TEE) transducer. Each lock-up required at least one system reboot to regain functionality. Customers are instructed to: 1) Determine the software version on their ultrasound system by: - Power up the system and allow it to complete the boot sequence; - Press Support on the right side of the control panel; - Under System Management, click System Information; - The software version is listed in the Software Information Section. 2) Circulate this notice to all users of this device so that they are aware of the product issue and associated hazard/harm. 3) Post this notice near the affected unit(s) for ease of reference. 4) Complete and return the response form to the Recalling Firm promptly and no later than 30 days from receipt via email to: ultrasound.corrections@philips.com or fax to 1-833-512-7756. In addition, because the software defect may intermittently cause the system to lock-up when exiting Review mode, customer are asked to take the following steps to minimize the likelihood of occurrence: 1. Acquire a loop while in xPlane, xPlane Doppler, or Dual mode. 2. Do NOT adjust an imaging control (for example: Rotate, Tilt, Gain) while the loop capture is in progress.* (*If the imaging controls have been adjusted during the loop capture, Philips recommends that the system be rebooted prior to reviewing the loop in Review mode). 3. Allow the loop
• Quantity in Commerce: Total = 10,583 systems (EPIQ and Afiniti)
• 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, 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IYO and Original Applicant = Philips Ultrasound, Inc.