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Artis Q Biplane, Model No. 10848282 recallZ-1495-2020 · Siemens Medical Solutions USA, Inc · initiated Feb 14, 2020

Class II Terminated All recalls posted in March 2020

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

A software issue could potentially cause the stand and table movements to be blocked.

FDA root cause category: Software design

What the company is doing

On February 14, 2020, the firm distributed Urgent Medical Device Correction letters to customers. Customers were informed of the software error which affects the listed systems. In case of software failure, planned procedures may have to be terminated and performed on an alternative x-ray system. Customers were instructed to do the following: Issue # 1: Potential issue with the Message "Stand battery charging: DO NOT POWER OFF" on Artis zeego systems Customer Action: Please check the system messages before power off/shutdown of the system. If possible, do not switch off the system while the message "Stand battery charging: DO NOT POWER OFF" is displayed and wait until the battery has been charged or replaced. Issue # 2: Potential issue of blocked stand movements on Artis zeego systems Issue # 3: Potential issue of blocked table movements on Artis zee/ Q/ Q.zen systems with Siemens Healthineers tables For Issues #2-3, customers may continue to use their systems, but in case the problem occurs, customers are instructed to follow standard emergency procedures in place in the event of system failures. Customers are encouraged to ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient. Siemens will correct the software error via a software update. Siemens' service organization will contact customers to arrange a date to perform this corrective action. For an earlier appointment, please contact the firm's service organization at 1-800-888-7436.

Recall details

Recall number
Z-1495-2020
Recall class
Class II
Status
Terminated
Initiated by the company
Feb 14, 2020
Posted by the FDA
Mar 13, 2020
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
1452 worldwide (638 US)
Product code
OWB
FDA submissions
K181407
Distribution
US Nationwide distribuiton.

Product description

Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

Serial numbers: 117316 109490 117021 121396 121185 121430 117012 121406 109141 109502 109123 121336 109400 109210 121089 109080 103061 109190 109191 109197 109198 121013 117136 117324 109418 109419 109421 121040 109405 109437 109119 109346 121445 121082 109460 121459 121011 109137 109512 117108 109300 121371 109187 121134 121374 109228 109412 109066 109067 109068 121053 121054 121422 117001 117023 109133 109134 121014 121112 121209 121325 109365 109217 109366 121357 109203 121051 109496 117330 109367 121402 103258 109542 121004 121167 121378 117329 121369 117315 121133 121163 121364 109202 121018 121154 121351 121354 117125 121418 121442 121151 121036 109500 117006 109451 121205 121340 121365 121137 109526 103013 109431 109383 121078 103053 121216 103035 109015 109136 117312 109132 117018 117124 109211 109144 109413 109482 109332 121381 109536 121457 121460 121352 121421 109309 117129 109488 117112 109304 109168 109520 121434 121165 121010 109501 121171 109162 109485 109507 109038 121210 121215 109040 109457 109183 121366 103285 103286 117020 109181 121370 121391 121384 109064 109009 121472 109226 109219 117030 109321 103230 121405 109330 103277 109452 121342 121301 109414 109380 121081 109076 109435 109179 109434 121424 109424 121315 109188 117029 103001 103239 109357 109432 117123 121355 109532 109071 109072 109075 109231 109355 109503 121179 117100 121140 121416 109090 121470 121417 109311 121106 109041 121411 109164 109167 121120 117134 117307 109373 109146 121144 121383 117117 109429 121047 117111 121312 117304 117024 121027 121359 121136 103028 121175 117127 121439 121173 121462 117325 109032 109463 109415 117303 117310 109524 121419 121435 121468 109461 121008 121152 109048 121155 121160 109301 109020 109036 109043 121433 121449 109336 109480 109320 109104 121379 109361 117314 121319 117309 121058 117113 117322 109158 117014 109031 117040 121211 117041 109318 109402 121375 121377 109010 121393 121071 117114 109349 109456 121034 117009 109069 109391 109416 109189 109214 121316 109331 121440 121079 121212 109044 121046 121072  ***Added 3/30/20*** 109016 121062 109118 117034 117026 121190 109302

Other devices under the same FDA submission

12 devices cleared under K181407 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 85071).

Sources and updates

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