EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231
Check against the official notice below — it lists the full affected range.
Philips Ultrasound is recalling EPIQ Diagnostic Ultrasound Systems in software versions 5.0, 5.0.1, and 5.0.2 across multiple models (EPIQ 5, 5C, 5G, 7, 7C, and 7G) due to 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 nationwide distribution across the United States, Puerto Rico, and numerous countries internationally.
The recall document does not specify a remedy for affected consumers. Consumers who believe they have an affected system should refer to the serial numbers and model information provided in the recall record or contact Philips Ultrasound directly for further guidance.
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: EPIQ Diagnostic Ultrasound Systems: EPIQ 5 Model Number: 795120 Serial Numbers/UDI Codes US118C0391/ (01)00884838047686(21)US118C0391; US118C1388/ (01)00884838047686(21)US118C1388; US118C1389/ (01)00884838047686(21)US118C1389; US119C0516/ (01)00884838047686(21)US119C0516; US119C0517/ (01)00884838047686(21)US119C0517; US119C0644/ (01)00884838047686(21)US119C0644; US121C0839/ (01)00884838047686(21)US121C0839; US219C0823/ (01)00884838047686(21)US219C0823; US219C0949/ (01)00884838047686(21)US219C0949; US319C0210/ (01)00884838047686(21)US319C0210; US518C1519/ (01)00884838047686(21)US518C1519; US518C1528/ (01)00884838047686(21)US518C1528; US719C0285/ (01)00884838047686(21)US719C0285; US719C0603/ (01)00884838047686(21)US719C0603; US918C0543/ (01)00884838047686(21)US918C0543; US918C1811/ (01)00884838047686(21)US918C1811; USD18C1243/ (01)00884838047686(21)USD18C1243; EPIQ 5C Model Number: 795205 Serial Numbers/UDI Codes US114C0239/ N/A; US114C0240/ N/A; US114C0241/ N/A; US114C0271/ N/A; US114C0272/ N/A; US114C0286/ N/A; US114C0287/ N/A; US114C0308/ N/A; US114C0366/ N/A; US117C0337/ (01)00884838047686(21)US117C0337; US215C0536/ N/A; US315C0582/ N/A; US316C0339/ N/A; US414C0158/ N/A; US514C0541/ N/A; US614C0745/ N/A; US614C0854/ N/A; US615C1170/ N/A; US615C1171/ N/A; US615C1172/ N/A; US617C0803/ (01)00884838047686(21)US617C0803; US617C0882/ (01)00884838047686(21)US617C0882; US715C0376/ N/A; US716C0748/ N/A; US717C0579/ (01)00884838047686(21)US717C0579; US815C1244/ N/A; US816C1004/ (01)0
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.