FDA Device recall Z-1330-2021
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia D…
- FDA Device
- Class II
- ongoing
- Published 2021-04-07
On 2021-04-07 the FDA classified a Class II recall of Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia D… by Siemens Medical Solutions Usa, citing the ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrec….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1330-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-02-04 |
| Published | 2021-04-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
Product
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
Reason
The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD, which may influence patient management decisions regarding induction of labor and elective caesarean delivery, which may result in premature births.
Identifiers
| code_info | Model: 11148775 Equipment Serial Numbers (U.S.) 800015 800101 800103 800104 800105 800106 800107 800108 800…Model: 11148775 Equipment Serial Numbers (U.S.) 800015 800101 800103 800104 800105 800106 800107 800108 800109 800111 800112 800113 800116 800118 800119 800121 800134 800138 800139 800141 800142 800143 800149 800150 800151 800152 800153 800155 800157 800158 800161 800165 800168 800172 800174 800175 800176 800177 800178 800182 800183 800184 800185 800186 800189 800190 800191 800192 800193 800194 800195 800196 800198 800199 800201 800203 800204 800205 800208 800209 800210 800211 800215 800217 800220 800221 800223 800225 800226 800227 800228 800229 800232 800233 800234 800235 800237 800239 800241 800242 800243 800244 800247 800249 800251 800254 800256 800257 800258 800259 800260 800263 800265 800267 800268 800270 800273 800274 800278 800280 800281 800285 800286 800291 800292 800293 800295 800300 800301 800302 800303 800304 800305 800308 800313 800314 800317 800319 8003 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1330-2021%22
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