FDA Device recall Z-2156-2017

AXIOM Sensis, Computer, Diagnostic, Programmable

FDA Device
Class II
terminated
Published 2017-05-31

On 2017-05-31 the FDA classified a Class II recall of AXIOM Sensis, Computer, Diagnostic, Programmable by Siemens Medical Solutions Usa, citing 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 fun….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2156-2017
Classification	Class II
Status	terminated
Initiated	2017-04-12
Published	2017-05-31
Last updated	2026-09-13 11:54 UTC
Company	Siemens Medical Solutions Usa
Distribution	US

Product

AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.

Reason

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.

Identifiers

code_info	Model no.: 10764561, 11007641, 6623974, 6634633, 6634641, 6634658 Serial Numbers: 2052 3021 2272 20356 20020 20… 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

code_info

Model no.: 10764561, 11007641, 6623974, 6634633, 6634641, 6634658 Serial Numbers: 2052 3021 2272 20356 20020 20…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2156-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.