{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "country": "United States", "city": "Malvern", "address_1": "40 Liberty Blvd", "reason_for_recall": "An extremely dusty computer can cause problems at system start, or rarely, cause system fail. Perform a system check prior to performing exams. If the Sensis system fails, its functions can not be used. Clinical treatment may need to be terminated, restarted, or transferred to a functioning system.", "address_2": "", "product_quantity": "4,095", "code_info": "Model no.: 10764561, 11007641, 6623974, 6634633, 6634641, 6634658 Serial Numbers: 2052 3021 2272 20356 20020 20059 2563 2571 2581 2582 2589 2593 100018 100036 41021 6108 2041 3365 3381 3382 3460 8001 20056 2348 3411 3428 20380 20634 3112 3383 22417 61012 2264 2291 2336 2411 2601 22215 8060 2508 22365 2586 2587 2588 60301 3405 3406 3440 3407 3408 3437 22267 61084 3546 60410 60138 60412 2407 3156 40108 2016 2702 3046 3073 3126 21120 22603 2181 2200 2294 21334 20109 20127 20160 20161 20660 60110 3417 3564 61072 60147 3240 3318 60396 60426 22648 20111 3603 2060 2154 2155 2201 3037 3041 3166 3224 3226 3352 3534 3536 22688 2573 3246 3257 3258 20017 20046 22219 21033 60370 60372 2517 60125 60128 60060 60120 60127 60129 60134 60143 61083 2744 2520 2521 3239 21222 21226 21244 21255 3458 20599 22345 22357 22366 60062 22249 2506 2709 2739 3072 20102 20134 20137 20149 20314 21212 2552 3060 20062 20574 6024 2034 2035 2525 2447 2594 3366 60347 60348 2442 2444 2500 2501 61031 2025 21496 22011 22025 2276 2408 20628 20642 60473 61002 3040 40007 20014 42320 2578 3621 3622 3623 3649 3650 3651 3653 3655 3670 3671 3676 21323 22423 22427 20448 60079 22217 2290 3463 21078 21079 21258 41202 2562 60151 61061 20065 3503 3504 3526 3527 22658 61025 21034 21035 21043 61086 22336 60369 60308 3261 60312 2527 20084 2420 2395 22225 20105 20573 20575 3512 2394 2042 3344 4003 21475 22251 60040 20495 41017 42308 21037 21051 21052 21095 21100 21102 21438 22022 60351 20100 20104 6050 2282 2301 2331 2332 2515 8067 8068 2156 60023 60024 60025 6101 20321 3390 20045 20047 6208 3136 3333 20598 3677 2142 2714 8009 2266 2531 2533 21391 22708 60052 6033 2304 2310 3173 61047 61048 61054 61059 60468 60322 20431 20436 2439 21463 21466 6638 6639 6720 6734 3416 3418 3419 3420 21392 21393 21394 20433 22069 40011 2426 2203 60332 20360 3134 3169 3230 3231 3233 3255 3256 21300 6503 2385 2410 3091 3097 2526 3461 3462 3620 20049 20397 20363 3445 3448 3475 21332 20015 60474 3627 3629 20383 60022 60089 41019 21106 21112 3059 3468 3472 3510 22671 2532 41018 21096 2434 60166 2072 2073 2074 2079 3403 3242 20372 20504 20525 20527 20528 20556 20557 20558 60087 20606 2230 2231 2362 2022 2032 2629 20392 3039 42209 41207 22310 22315 20506 21299 21311 21312 21315 3336 3337 3338 3339 6049 6100 6114 2215 20608 60106 60160 6736 40000 40001 3694 20000 20001 20002 20004 100014 100015 100016 100017 3423 60418 61019 2097 2263 3139 21041 22211 60398 42109 22406 2111 3038 20048 2425 22252 21086 21416 22218 22498 22504 22511 22519 60131 60342 20488 22521 22454 60458 60461 60462 60467 61024 6625 21363 22490 8051 8052 3269 3319 60437 2139 2140 20622 6702 21399 22037 60325 21339 21367 21377 21382 21386 60316 3575 3601 21385 22510 3581 21474 3438 21341 21342 21384 21395 21452 40107 22487 60436 60444 60453 61064 61088 2403 20407 20033 20051 22509 3075 2086 2225 20430 61009 21076 22282 6110 2113 2186 2187 3049 3050 22461 22462 22415 60058 60095 60311 3070 22312 20412 60395 20550 20549 21011 21490 2077 6740 20594 20637 22611 22704 3215 6628 3682 3683 3690 3691 21465 22663 22667 61014 3523 60323 61008 3069 3128 3129 21365 2613 3267 60020 3078 3102 3247 21064 60359 20026 2597 2639 21000 3545 3547 20466 3316 22512 6631 6632 40012 3057 3140 3142 3321 22437 22438 60075 60082 2608 60171 2280 22605 6105 2160 2162 2169 3619 60148 3529 20560 6622 3641 20538 21138 22341 21109 21383 3268 6727 2349 2350 2352 22436 60427 2340 2368 2374 20395 2443 20605 20162 22612 21297 22000 2242 3347 3348 3349 3350 20133 20354 40153 2168 3410 6103 2269 2205 2224 2227 2229 2270 20107 20457 20596 21056 22699 22700 22702 3163 2293 6035 3218 22038 3205 3206 22628 22651 22652 22670 60111 3047 2178 2190 20016 3340 21020 21025 20302 20303 20645 100006 20559 100005 21498 20585 20023 20030 20399 2576 21098 60123 61081 22522 20385 2713 2567 2189 2428 2565 2566 3015 3051 20319 20561 22474 22480 4603 8100 60167 60355 61030 20618 3642 2299 3001 3415 20069 3014 3103 3432 3434 3464 20389 20546 60065 22523 22526 22528 22619 22623 22627 22646 22669 22681 22682 22720 20139 22051 60480 6138 2384 3005 3006 3007 3009 3010 21298 2572 2590 22450 20391 2150 2151 20006 21014 22420 21074 21077 60154 61071 20021 2706 3248 3572 3573 21237 3647 21388 3660 60146 3101", "center_classification_date": "20170523", "distribution_pattern": "Nationwide Distribution", "state": "PA", "product_description": "AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.", "report_date": "20170531", "classification": "Class II", "openfda": {}, "recalling_firm": "Siemens Medical Solutions USA, Inc", "recall_number": "Z-2156-2017", "initial_firm_notification": "Letter", "product_type": "Devices", "event_id": "77016", "termination_date": "20180515", "more_code_info": "", "recall_initiation_date": "20170412", "postal_code": "19355-1418", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Terminated" } ] }