FDA Device recall Z-0547-2022
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
- FDA Device
- Class II
- ongoing
- Published 2022-02-09
On 2022-02-09 the FDA classified a Class II recall of ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B by Siemens Medical Solutions Usa, citing due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0547-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-12 |
| Published | 2022-02-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
Reason
Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a patient's condition.
Identifiers
| code_info | Software Version VA25A/B System Serial Numbers: 800101 800106 800117 800126 800135 800136 800138 800140 800142 800147…Software Version VA25A/B System Serial Numbers: 800101 800106 800117 800126 800135 800136 800138 800140 800142 800147 800157 800159 800162 800163 800171 800176 800177 800181 800182 800183 800184 800185 800186 800187 800190 800191 800192 800196 800199 800203 800205 800206 800207 800211 800212 800213 800218 800219 800220 800223 800225 800226 800228 800229 800230 800232 800236 800237 800241 800244 800249 800250 800251 800255 800256 800258 800260 800265 800267 800273 800275 800278 800279 800281 800285 800286 800288 800290 800291 800292 800294 800295 800302 800304 800305 800314 800315 800319 800328 800334 800335 800338 800339 800341 800346 800356 800357 800360 800362 800368 800369 800371 800375 800383 800388 800390 800391 800397 800399 800405 800406 800408 800411 800426 800428 800433 800435 800436 800439 800449 800451 800454 800458 800463 800464 800466 800467 800468 800472 800473 800474 800483 800490 800517 800530 800532 800535 800545 800549 800551 800555 800557 800559 800566 800575 800585 |
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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-0547-2022%22
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