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U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe

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  Class 2 Device Recall ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe see related information
Date Initiated by Firm March 07, 2014
Date Posted April 03, 2014
Recall Status1 Terminated 3 on November 12, 2015
Recall Number Z-1331-2014
Recall Event ID 67741
510(K)Number K121384  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348).

Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
Code Information Model number 10433816 - ACUSON P3000 Ultrasound System; Model numbers 10852384 - P300 PA 320E transducer. Serial numbers: 105 106 114 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 148 149 150 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 178 186 187 188 189 193 194 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 257 258 259 260 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 330 331 334 336 337 339 340 341 342 343 344 345 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 371 373 374 375 377 378 379 380 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 400 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 421 422 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 445 446 447 448 449 450 451 452 453 454 455 456 457 458 459 460 461 462 463 464 465 466 467 468 469 470 471 472 475 476 477 478 479 480 481 482 483 484 485 486 487 488 489 490 491 492 493 494 495 496 497 498 501 506 507 508 509 510 511 512 513 515 516 518 519 520 521 522 526 527 529 530 535 536 537 538 539 540 541 542 544 545 546 547 548 549 550 551 552 553 554 555 556 557 558 559 560 561 562 563 564 565 566 567 568 569 596 597 598 601 602 603 604 605 606 607 608 610 614 615 616 617 618 619 620 621 622 624 627 628 629 630 633 634 635 636 637 638 639 640 641 642 643 644 646 647 648 650 651 652 653 654 655 656 657 659 660 661 662 663 664 665 666 667 668 669 670 671 672 674 675 676 678 679 680 681 682 683 684 685 686 687 689 693 694 696 697 698 699 704 706 707 709 710 711 712 713 718 719 720 721 722 723 724 725 727 728 729 730 731 732 733 734 737 739 743 745 746 747 748 749 750 751 752 753 754 755 757 758 759 760 761 762 763 764 765 766 767 768 769 770 771 772 773 775 776 777 778 779 782 783 784 785 791 792 793 794 795 796 797 798 800 801 806 807 808 810 811 812 814 815 816 817 818 819 821 822 823 824 825 826 827 828 829 830 832 834 835 836 837 838 839 840 841 842 843 845 847 848 853 854 855 856 857 858 860 861 862 863 864 865 866 872 879 881 890 892 893 894 895 896 897 898 900 901 902 903 904 909 910 911 912 913 914 919 920 929 933 934 935 936 937 938 939 940 941 942 943 944 945 946 947 948 949 950 951 952 957 958 959 960 961 962 963 964 965 967 969 970 972 973 974 975 976 977 979 980 981 985 986. 
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc.
685 E Middlefield Rd
Mountain View CA 94043-4045
For Additional Information Contact Sheila Pickering, Ph.D.
650-694-5398
Manufacturer Reason
for Recall
ACUSON P300 ultrasound systems using the PA230 transducer with a user-defined preset which includes the 100% setting for output power could cause the transducer surface temperature to exceed the maximum allowable limit.
FDA Determined
Cause 2
Device Design
Action Siemens sent an Customer Safety Advisory Notifications on March 7, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A new version of software resolving this error will be provided free of charge. Your local Customer Service Engineer will contact you to schedule an appointment to make the necessary repairs on your system. If you have any questions, please contact your local service support person for information regarding timelines and status. Until the necessary repairs have been completed on your system, please share this information with all personnel within your organization who need to be aware of this issue. As always, patient safety issues are a high priority. To date, no patient injury has been reported. This problem was discovered as part of our ongoing quality process. For further questions please call (650) 694-5398. We sincerely regret any inconvenience this condition may cause in your daily operations.
Quantity in Commerce 675
Distribution Class II Recall - Worldwide Distribution - US Distribution and the countries of Australia, Austria, Belgium, Bhutan, Bolivia, Botswana, Bulgaria, Canada, Chile, Colombia, Croatia, Dem. Rep. Congo, Denmark, Ecuador, France, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Ivory Coast, Japan, Kuwait, Malaysia, Mauritius, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Republic Korea, Romania, Saudi Arabia, Serbia, Seychelles, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad,Tobago, Turkey, U.A.E. and United Kingdom.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = ESAOTE, S.P.A.
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