Reported Aug 22, 2018 · Terminated

Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage:…

Siemens Medical Solutions USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418

Is this the product you have?

    • Artis Q. angiography system. Model 10848280
    • 10848281
    • 10848282
    • 10848283
    • 10848353
    • 10848354 & 10848355
  • Product UsageArtis 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
Lot codes and dates
  • 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

    209 of 209 codes

    • 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
  • Model 10848282 - Serial Numbers

    177 of 177 codes

    • 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
  • 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
Amount recalled
605 units in total

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Potential hardware issue which may cause thermal effects and possible damage to system parts.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 15, 2020 · Data as of Sep 19, 6:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.