CLASS II ONGOING Device recall · Reported 28 Dec 2022 · FDA Enforcement Report
Vivid q ultrasound recalled by GE Medical Systems
GE Medical Systems is recalling Vivid q ultrasound, distributed nationwide in the US. The recall was initiated on 10 Nov 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0757-2023
- FDA event ID
- 91139
- Recalling firm
- GE Medical Systems, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Nov 2022
- FDA classified
- 22 Dec 2022
- Reported
- 28 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 10 Nov 2022 | Recall initiated by company | |
| 22 Dec 2022 | Classified by FDA | +42 days |
| 28 Dec 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.
Product as listed by the FDA
Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
Where it was distributed
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, 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, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, AZERBAIJAN, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Chile, CHINA Colombia, CONGO, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, CZECH REPUBLIC, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, HONG KONG, Hungary, ICELAND, INDIA, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kosovo, Kuwait, KYRGYZSTAN, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, LUXEMBOURG, Macedonia, MALAYSIA, Mali, Mauritania, Mauritius, Mexico, MICRONESIA, Moldova, Morocco, Mozambique, Namibia, Nepal, Netherlands, NEW ZEALAND, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, SYRIA, TAIWAN, TANZANIA, THAILAND, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Is Vivid q ultrasound recalled?
Yes. GE Medical Systems recalled Vivid q ultrasound on 10 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-0757-2023.
Why was it recalled?
Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.
Which lots are affected?
Model Number (System ID): H45021WZ (VQ20056, VQ20718, VQ020015, VQ20399, VQ202400, VQ20127, VQ20529, VQ20505, VQ20502, VQ20533, VQ20741, VQ20683, VQ20653, VQ20700, VQ20580, VQ20477, VQ20498, VQ020516, VQ020216, VQ20507, VQ20772, VQ20686, VQ20043, VQ20508, VQ20566, VQ20620, VQ20525, VQ20483, VQ20601, VQ20706, VQ20591, VQ20122, VQ20668, VQ020275, VQ20713, VQ20198, VQ20863, VQ20052, VQ20597, VQ20619, VQ20614, VQ020676, VQ20154, VQ20584, VQ20599, VQ20204, VQ20429, VQ20284, VQ20045, VQ20568, VQ20562, VQ020662, VQ20524, VQ20730, VQ20628, VQ20287, VQ20266, VQ20569, VQ20110, VQ20116, VQ20109, VQ20560, VQ20671, VQ20278, VQR20075, VQ20504, VQ20607, VQ20007, VQ20054, VQ20611, VQR020000, VQ20910, VQ20133, VQ20108, VQ20415, VQ20469, VQ20367, VQ20341, VQ20051, 516663VIVIDQ, VQ20755, VQ30010LO, VQ20715, VQ020732, VQ020745, VQ20585, VQ20288, VQ20412, VI002091, VQ20712, VQ20702, VQ20464, VQ20417, VQ20638, VQ20722, VQ20747, VQ20593, VQ20456, VQ20326, VQ20181, VQ20773, VQ20522, VQ20081, VQ20521, 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N001US25, L005US02, M007US19, A111US09, A111US08, O020US06, O020US05, E001US89, E001US67, O010US12, O010US10, R002US50, R002US52, A007US55, A022US45, A010US66, A044US20, A022US56, P001US30, 363020US04, 547150US04, 529030US16, 103000US05, 547010US09, 262020US05, 501464US05, 547010US08, 529050US12, 913758US02, 913758US01, 756020US03, 795020US07, 122201US01, 652040US07, 225030US22, 529150US37, 252631US01, 482893US02, 0853380264, 0853380271, 0853380282, 0853380288, 0853380304, 0853380310, 0853380342, 0853380347, 0853380350, 0853380354, 0853380359, 0853380364, 0853380365, 0853380366, 0853380371, 0853380372, 0853380373, 0856380264, 0856380279, 0856380286, 0856380293, 0856380297, 0856380314, 0856380319, 1573UL0210, 0856380307, 0856380338, 0856380345, 1573UL0084, 1573UL0429, 1573UL0390, 99999ULT71, UA4338US03, UA4338US01, UA4338US02, UA4329US04, IE1566US10, 10010ULT17, IE1503US09, IE1511US11, IE1511US09, IE1504US10, IE1566US09, 00361ULT13, 21200ULT01, 00361ULT12, 05452ULT10, 05452ULT05, 11337ULT21, 11337ULT25, 21097US234, 21097US024, 21097US073, 00272ULT39, 10778ULT03, 106379792, 11254ULT01, 00105ULT12, 00105ULT10, 00631ULT31, 00094ULT09, 00001ULT62, 00243ULT36, 193590632, 195867652, 00991ULT12, 176364322, 21289ULT01, 21344ULT01, 00109ULT21, 00109ULT13, 20249ULT03, 00681ULT25, 00681ULT22, 120781342, 1910424082, 00006ULT09, 00149ULT35, 00018ULT23, 00463ULT08, 167422792, 21325ULT04, 21325ULT06, 21325ULT03, 21325ULT14, 21325ULT01, 21325ULT15, 21325ULT05, 21325ULT16, 21325ULT17, 21325ULT02, 11846ULT01, 11071ULT01, 00130ULT19, 21268ULT01, 140245462, 11443ULT01, GB1169US02, 77526ULT04, GB1321US01, 152439116, 00383ULT14, 21234ULT43, 00060ULT60, 21234ULT30, 00028ULT61, 00028ULT62, 21065ULT02, 21234ULT32, 20622ULT04, 20308ULT02, 21234ULT20, 20622ULT03, 10653ULT04, 10397ULT12, 21234ULT31, 21234ULT22, 175899652, 11318ULT02, 11318ULT01, 00229ULT14, 00232ULT25, 20158ULT16, 10812ULT01, 10812ULT02, 11019ULT01, 00506ULT18, 20297ULT22, 21260ULT01, 20666ULT01, 00392ULT02, 00095ULT66, 1961973872, 1961973892, GB1040US01, 00020ULT16, 21148ULT02, 21303ULT05, 00285ULT20, 00285ULT24, 00285ULT21, VQ56262VQ, VQ55178VQ, VQ55849VQ); H45041G (83110090682, 83112469417, 83114483855, 83129518957, 83130057214, 83130057281, 83145121565, 83164179701, VQ55483VQ, VQ56025VQ, VQ55480VQ, VQ20859VQ, VQ55667VQ, VQ55359VQ, VQ55739VQ, VQ55138VQ, VQ55198VQ, RU9241US03, RU6213US02, RU3636US02, RU8221US05, RU5081US02, RU7648US01, RU8618US02, RU3584US02, RU5894US02, RU3532US05, RU6551US06, RU6551US07, RU7175US07, RU7175US22, RU7175US24, RU7932US03, RU8299US03, RU8379US01, RU8673US01, RU6235US02, RU9405US01, RU3970US06, RU3798US02, RU8996US01, RU8314US01, RU8921US02, RU9235US01, RU3919US01, RU6396US06, RU5026US02, 0853380319, 0853380327, 0853380328, 0853380331, 00028ULT73, VQ055300VQ); H45041SX (83129185778)
Where was it sold?
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, 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, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, AZERBAIJAN, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Chile, CHINA Colombia, CONGO, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, CZECH REPUBLIC, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, HONG KONG, Hungary, ICELAND, INDIA, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kosovo, Kuwait, KYRGYZSTAN, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, LUXEMBOURG, Macedonia, MALAYSIA, Mali, Mauritania, Mauritius, Mexico, MICRONESIA, Moldova, Morocco, Mozambique, Namibia, Nepal, Netherlands, NEW ZEALAND, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, SYRIA, TAIWAN, TANZANIA, THAILAND, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Device | CLASS II | Optima XR240amx, Mobile Digital Radiographic System recalled | GE Medical Systems | Device Malfunction | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |