FDA Device recall Z-0709-2018

Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory

FDA Device
Class II
terminated
Published 2018-03-07

On 2018-03-07 the FDA classified a Class II recall of Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory by Siemens Medical Solutions Usa, citing the possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0709-2018
Classification	Class II
Status	terminated
Initiated	2017-09-28
Published	2018-03-07
Last updated	2026-09-13 11:54 UTC
Company	Siemens Medical Solutions Usa
Distribution	AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY

Product

Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.

Reason

The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no longer be able to be used to release radiation. The hand switch provided can be used to release exposures; however, fluoroscopic examinations will not be possible.

Identifiers

code_info	Serial Numbers: 10000 10003 10006 10007 10008 10009 10012 10014 10020 10021 10022 10024 10025 10029 10031… Serial Numbers: 10000 10003 10006 10007 10008 10009 10012 10014 10020 10021 10022 10024 10025 10029 10031 10036 10038 10039 10041 10042 10045 10046 10050 10052 10056 10057 10058 1005873 10059 10070 10075 10079 10081 10095 10096 10098 10099 10100 10107 10118 10127 10130 10133 10137 10138 10139 10140 10142 10146 10147 10152 10153 10157 10162 10163 10164 10166 10168 10179 10192 10194 10196 10197 10206 10207 10217 10226 10228 10234 10236 10237 10252 10262 10263 10264 10267 10275 10282 10288 10291 10294 10297 10298 10299 10306 10308 10314 10315 10316 10320 10322 10324 10325 10333 10342 10343 10344 10345 10346 10347 10348 10349 10352 10354 10355 10361 10365 1038 10380 10381 10382 10383 10384 10399 1040 10404 10405 10408 10418 10419 10422 10426 1043 10430 10435 10436 10438 10442 10443 10449 10451 10454 10456 1046 10462 10467 10468 10469 1051 1059 1067 10

code_info

Serial Numbers: 10000 10003 10006 10007 10008 10009 10012 10014 10020 10021 10022 10024 10025 10029 10031…

Serial Numbers: 10000 10003 10006 10007 10008 10009 10012 10014 10020 10021 10022 10024 10025 10029 10031 10036 10038 10039 10041 10042 10045 10046 10050 10052 10056 10057 10058 1005873 10059 10070 10075 10079 10081 10095 10096 10098 10099 10100 10107 10118 10127 10130 10133 10137 10138 10139 10140 10142 10146 10147 10152 10153 10157 10162 10163 10164 10166 10168 10179 10192 10194 10196 10197 10206 10207 10217 10226 10228 10234 10236 10237 10252 10262 10263 10264 10267 10275 10282 10288 10291 10294 10297 10298 10299 10306 10308 10314 10315 10316 10320 10322 10324 10325 10333 10342 10343 10344 10345 10346 10347 10348 10349 10352 10354 10355 10361 10365 1038 10380 10381 10382 10383 10384 10399 1040 10404 10405 10408 10418 10419 10422 10426 1043 10430 10435 10436 10438 10442 10443 10449 10451 10454 10456 1046 10462 10467 10468 10469 1051 1059 1067 10

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-0709-2018%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.