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Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 108...

FDA Device Recall #Z-3189-2018 — Class II — July 29, 2018

Recall Summary

Recall Number Z-3189-2018
Classification Class II — Moderate risk
Date Initiated July 29, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices
Quantity 429 total

Product Description

Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355

Reason for Recall

Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).

Distribution Pattern

US nationwide distribution.

Lot / Code Information

103221 103061 103217 103030 103218 103220 103013 103053 103039 103050 103008 103207 103222 103035 103001 103048 103028 103212 103040 109033 109135 109141 109123 109344 109210 109080 109074 109352 109388 109190 109191 109197 109198 109305 109119 109346 109016 109118 109166 109137 109155 109379 109300 109187 109228 109327 109066 109067 109068 109084 109133 109134 109365 109217 109366 109203 109011 109367 109169 109096 109159 109358 109202 109130 109378 109384 109143 109102 109383 109015 109211 109144 109332 109309 109304 109168 109227 109057 109221 109162 109108 109103 109165 109038 109040 109324 109183 109034 109129 109181 109029 109136 109064 109009 109194 109132 109226 109219 109321 109330 109058 109145 109050 109380 109222 109224 109225 109076 109386 109179 109007 109188 109229 109357 109071 109072 109075 109231 109355 109091 109393 109090 109311 109041 109164 109167 109039 109362 109060 109146 109088 109373 109364 109092 109032 109021 109171 109048 109172 109301 109020 109036 109043 109326 109336 109320 109163 109101 109104 109105 109107 109302 109369 109361 109186 109371 109069 109158 109047 109031 109027 109028 109318 109120 109010 109093 109350 109232 109156 109157 109307 109308 109349 109391 109189 109214 109331 109044 121185 121061 121195 121336 121089 121094 121169 121006 121013 121040 121368 121208 121062 121082 121011 121039 121371 121134 121374 121053 121054 121014 121112 121209 121325 121357 121051 121004 121167 121369 121133 121200 121163 121364 121314 121018 121154 121351 121354 121151 121036 121205 121340 121365 121137 121324 121012 121049 121078 121216 121333 121183 121019 121352 121165 121010 121148 121171 121139 121081 121210 121215 121366 121109 121323 121370 121096 121332 121015 121344 121115 121309 121204 121305 121016 121342 121301 121190 121315 121138 121372 121355 121193 121020 121179 121188 121161 121140 121168 121106 121321 121120 121121 121122 121144 121047 121312 121201 121088 121027 121359 121136 121141 121322 121069 121175 121173 121009 121056 121057 121034 121008 121152 121155 121160 121356 121319 121058 121085 121211 121187 121197 121375 121206 121361 121071 121339 121199 121310 121362 121316 121023 121079 121212 121041 121037 121046 121313 121072 117012 117136 117324 117108 117001 117023 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 105033 105032 105007 105105 105028 105018 105025 105016 105026 105027 105017 105100 105029 105030 105031 111005 111002 111103 111109 111003 111101 111011 111017 111010 111000 111104 111012 111107 111106 123026 123043 123031 123053 123202 123050 123008 123035 123211 123003 123011 123032 123208 123209 123013 123014 123206 123207 123213 123025 123036 123022 123205 123201 123023 123024 123027 123049 123055 123056 123037 123216 123010 123046 123052 123200 123015 123016 123212

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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