{ "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": "2026-04-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "country": "United States", "city": "Malvern", "address_1": "40 Liberty Blvd", "reason_for_recall": "Potential hardware issue which may cause thermal effects and possible damage to system parts.", "address_2": "", "product_quantity": "605 units in total", "code_info": "Model 10848280 - Serial Numbers: 103221 103061 103232 103217 103030 103218 103220 103013 103053 103039 103050 103008 103207 103222 103035 103230 103258 103001 103239 103263 103048 103028 103241 103212 103254 103255 103257 103245 103040 103253 Model 10848281 - Serial Numbers: 109033 109135 109141 109502 109123 109400 109344 109210 109080 109074 109417 109352 109388 109479 109418 109190 109191 109197 109198 109305 109405 109437 109119 109346 109419 109421 109016 109118 109493 109166 109496 109460 109137 109155 109379 109300 109187 109228 109327 109412 109066 109067 109068 109084 109133 109134 109365 109217 109366 109203 109011 109367 109169 109096 109159 109358 109202 109130 109490 109378 109384 109500 109451 109504 109505 109143 109431 109102 109445 109383 109407 109015 109211 109144 109413 109482 109332 109309 109488 109304 109168 109227 109467 109057 109221 109484 109401 109501 109162 109108 109485 109103 109165 109038 109040 109324 109457 109183 109034 109129 109181 109029 109136 109442 109064 109009 109194 109132 109226 109219 109321 109330 109058 109145 109050 109414 109380 109222 109224 109225 109076 109435 109386 109179 109432 109434 109007 109424 109188 109458 109229 109357 109071 109072 109075 109231 109355 109503 109091 109393 109090 109311 109041 109497 109164 109167 109039 109362 109060 109146 109429 109088 109373 109397 109426 109452 109364 109092 109032 109463 109415 109021 109461 109171 109048 109172 109301 109020 109036 109043 109326 109336 109480 109320 109163 109101 109104 109105 109107 109302 109369 109361 109186 109371 109069 109158 109047 109031 109027 109028 109318 109120 109402 109010 109093 109350 109232 109156 109157 109307 109308 109411 109349 109456 109391 109189 109214 109331 109044 Model 10848282 - Serial Numbers: 121185 121430 121406 121061 121195 121336 121089 121094 121169 121006 121013 121040 121368 121208 121445 121446 121062 121448 121082 121011 121039 121371 121134 121374 121053 121054 121422 121014 121112 121209 121325 121357 121051 121402 121004 121167 121378 121369 121133 121200 121163 121364 121314 121396 121018 121154 121351 121354 121418 121442 121151 121036 121205 121340 121365 121137 121324 121012 121049 121078 121216 121333 121183 121019 121381 121352 121421 121434 121165 121415 121010 121148 121171 121139 121081 121210 121215 121379 121366 121109 121323 121370 121391 121384 121096 121332 121015 121395 121344 121115 121405 121309 121204 121305 121016 121342 121301 121190 121424 121315 121138 121436 121372 121355 121193 121020 121179 121188 121161 121140 121416 121417 121168 121106 121321 121411 121120 121121 121122 121144 121383 121047 121312 121407 121201 121088 121027 121359 121136 121141 121322 121444 121069 121175 121439 121173 121009 121056 121057 121419 121435 121034 121008 121152 121155 121160 121433 121449 121356 121319 121058 121085 121431 121211 121187 121197 121375 121377 121412 121206 121393 121361 121071 121339 121199 121310 121362 121316 121440 121023 121079 121212 121041 121037 121046 121313 121072 Model 10848283 - Serial Numbers: 117012 117136 117324 117108 117001 117023 117330 117329 117315 117021 117316 117125 117029 117006 117312 117129 117112 117034 117020 117018 117124 117030 117026 117123 117100 117134 117307 117117 117111 117304 117024 117127 117325 117303 117310 117314 117309 117113 117322 117014 117040 117041 117114 117009 Model 10848353 - Serial Numbers: 105033 105032 105007 105105 105028 105110 105120 105018 105119 105114 105115 105025 105016 105026 105027 105017 105100 105112 105029 105030 105031 Model 10848354 - Serial Numbers: 111005 111122 111124 111125 111002 111113 111103 111109 111121 111003 111110 111101 111011 111017 111010 111115 111116 111117 111118 111119 111120 111000 111104 111112 111012 111107 111106 111123 Model 10848355 - Serial Numbers: 123225 123026 123043 123031 123236 123053 123202 123050 123008 123035 123211 123003 123011 123032 123208 123209 123231 123013 123014 123206 123207 123219 123213 123025 123036 123220 123221 123222 123022 123229 123205 123201 123023 123024 123235 123224 123232 123233 123234 123027 123049 123230 123055 123056 123037 123216 123010 123046 123052 123200 123015 123016 123212", "center_classification_date": "20180810", "distribution_pattern": "US Nationwide Distribution", "state": "PA", "product_description": "Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 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. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.", "report_date": "20180822", "classification": "Class II", "openfda": {}, "recalling_firm": "Siemens Medical Solutions USA, Inc", "recall_number": "Z-2747-2018", "initial_firm_notification": "Letter", "product_type": "Devices", "event_id": "80586", "termination_date": "20200115", "more_code_info": "", "recall_initiation_date": "20180622", "postal_code": "19355-1418", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Terminated" } ] }