United StatesWhat's being recalled
Philips Lumify Diagnostic Ultrasound System
Recalling firm: Philips Ultrasound, LLC, Bothell, WA, United States.
How to identify it
UDI-DI/Software Version: Android: 00884838122116/1.X, 3.X, 4.X, 5.X. iOS: 00884838124141/2.X and 5.X
The hazard
Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable outside of the hospital (ambulances/aircraft/field); 2) At connection between transducer USB cable to tablet/phone, there may be an unstable connection/may disconnect disrupting function. May cause diagnosis/treatment delay.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution including in the states of CA, MA, IL, NY, OR, GA, TX, WA, FL, PA, WI, LA, NJ, KY, VA, MS, AZ, SC, CT, MN, UT, OH, AL, MI, NH, MO, TN, IN, DC, NE, NM, MT, NV, NC, MD, IA, SD, VT, KS, AK, CO, ID, OK, WV, AR, RI, ME, WY, HI, DE, ND and the countries of CA, NO, HR, DE, KR, GB, ES, FI, PL, AU, TH, SG, NL, RO, CH, FR, MM, MX, BE, DK, MY, SE, LB, SI, BR, CL, GR, PH, CN, ID, LT, HK, MQ, JP, IT, IE, IL, AT, TW, AE, SA, HU, RU, VN, NZ, TR, SK, ZA, KE, AR, NP, PK, UY, DO, MN, LK, GT, BD, IS, IN, NI, LY, CY, CZ, SV, PA, BG, PE, EC, CO, VE, UZ, YE, KW, DZ, LU, EG, EE, UA, LV, KZ, TZ, MD, JO, GY, QA, MU, AM, OM, PT, TN, NG, BO, PF, ZM, GF, YT, ME, GD, RS, BW, GP, RE, MT, CR, MA, CI, NC, BA, SR, CG, TL, GH, AL, MV, XK, BN, LS, MK, CM, TT, ZW, BH, PS, HN, MC, WS, JE, PM, AZ.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)