Recall Z-0757-2023
GE Medical Systems, LLC · initiated November 10, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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).
Codes / lots: 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, VQR20082, VQ20673, VQ20519, VQ20018, VQ020749, VQ20571, VQ020577, VQ20654, VQ20735, VQ20074, VIQ622774CART, VQ20458, VQ20841, VQ20867, VQ20828, VQ003479, VQ20721, VQ20067, VQ20436, VQ20512, VQ20493…
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.
FDA-determined cause: Device Design
Action taken
GE Healthcare notified consignees on about 11/10/2022 via letter titled "URGENT MEDICAL DEVICE CORRECTION. For U.S. customers, letters were sent via FedEx. Consignees were instructed to follow updated safety instructions provided in the appendix included with the notification letter, place the appendix with the product labeling, and replace the batter every 2 years or if the battery is not capable of powering the system for more than 30 minutes. In response, GE Healthcare requested consignees return the response form.
Details
- Recall number
- Z-0757-2023
- Initiated
- November 10, 2022
- Posted by FDA
- December 22, 2022
- Product code
- ITX – Transducer, Ultrasonic, Diagnostic
- Quantity
- 2,609 units
- Distribution
- 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…
- Recalling firm
- GE Medical Systems, LLC, Waukesha, WI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0752-2023 Class II | Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics…Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they… | 11/10/2022Open, Classified |
| Z-0753-2023 Class II | Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics…Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they… | 11/10/2022Open, Classified |
| Z-0754-2023 Class II | Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis…Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they… | 11/10/2022Open, Classified |
| Z-0755-2023 Class II | Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis…Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they… | 11/10/2022Open, Classified |
| Z-0756-2023 Class II | Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525…Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they… | 11/10/2022Open, Classified |
| Z-0758-2023 Class II | Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in…Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they… | 11/10/2022Open, Classified |
| Z-0759-2023 Class II | Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in…Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they… | 11/10/2022Open, Classified |