CLASS II Device recall · Reported 15 Jan 2020 · FDA Enforcement Report

Cios Alpha recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Cios Alpha, distributed nationwide in the US. The recall was initiated on 25 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 11294 11202 12009 11141 11163 11032 11311 11260 11258 12530 12334 11376 12426 11336 11132 11295 11044 11005 11333 11386 12597 10076 12677 10115 11291 12523 11056 12319 12623 12512 12574 12647 12014 12452 12306 12317 11119 12576 12678 12513 12335 12490 12657 11200 11281 11283 12425 12023 12396 11285 11205 11103 11105 11257 11074 12379 11013 10021 11330 11066 10057 11143 11077 11319 11240 11349 11098 12339 11153 11372 10037 11328 12529 12308 10063 11106 12373 12584 11067 10082 12026 12027 11168 12492 10019 11317 10035 11198 12040 12307 12440 11165 12611 11094 11226 11370 12377 11348 11009 11018 10058 12321 12004 11378 11167 11248 11306 11229 12028 11144 12313 11287 12654 12043 11038 12320 12514 11352 12612 11316 11243 11314 12626 11374 11162 11292 12394 12498 12549 11120 11134 12494 12526 12528 11219 11220 11346 12318 12562 12607 12644 12685 12025 12046 11363 11288 11356 12620 11124 11251 12322 12323 12617 12533 12504 11015 11016 12486 12515 12500 11104 11327 10096 12391 11315 11075 12622 12652 11290 12416 12472 12496 12552 10116 12578 12642 12599 11280 11035 12003 12655 12030 11359 11107 12314 12618 11338 11064 12457 12460 Serial Numbers added as of 1/20/20: 10078 10089 11082 11080 11246 11380 11379 12006 12557 12718 12735 12732

Quantity recalled190 (updated total of 202 as of 1/20/20)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0782-2020
FDA event ID: 84433
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 25 Nov 2019
FDA classified: 7 Jan 2020
Reported: 15 Jan 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Imaging Equipment

Timeline

25 Nov 2019	Recall initiated by company
7 Jan 2020	Classified by FDA	+43 days
15 Jan 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

During a routine inspection of a system, a crack on the C-arm holder was discovered. In the event the C-arm holder has a crack, the stability of the C-arm may be compromised and could lead to deformations of the C-arm. In very unlikely cases, an extreme impact to the C-arm such as heavy collision with a wall or table, may lead to a detachment of the C-arm and could potentially result in injury to patients and staff.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application

Where it was distributed

US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WI.

Nationwide Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Illinois Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Numbers: 11294 11202 12009 11141 11163 11032 11311 11260 11258 12530 12334 11376 12426 11336 11132 11295 11044 11005 11333 11386 12597 10076 12677 10115 11291 12523 11056 12319 12623 12512 12574 12647 12014 12452 12306 12317 11119 12576 12678 12513 12335 12490 12657 11200 11281 11283 12425 12023 12396 11285 11205 11103 11105 11257 11074 12379 11013 10021 11330 11066 10057 11143 11077 11319 11240 11349 11098 12339 11153 11372 10037 11328 12529 12308 10063 11106 12373 12584 11067 10082 12026 12027 11168 12492 10019 11317 10035 11198 12040 12307 12440 11165 12611 11094 11226 11370 12377 11348 11009 11018 10058 12321 12004 11378 11167 11248 11306 11229 12028 11144 12313 11287 12654 12043 11038 12320 12514 11352 12612 11316 11243 11314 12626 11374 11162 11292 12394 12498 12549 11120 11134 12494 12526 12528 11219 11220 11346 12318 12562 12607 12644 12685 12025 12046 11363 11288 11356 12620 11124 11251 12322 12323 12617 12533 12504 11015 11016 12486 12515 12500 11104 11327 10096 12391 11315 11075 12622 12652 11290 12416 12472 12496 12552 10116 12578 12642 12599 11280 11035 12003 12655 12030 11359 11107 12314 12618 11338 11064 12457 12460 Serial Numbers added as of 1/20/20: 10078 10089 11082 11080 11246 11380 11379 12006 12557 12718 12735 12732

Where was it sold?

US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono biplane recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono floor recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
10 Jun 2026Device	CLASS II	Artis pheno recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	PA

Other Imaging Equipment recalls

All 2,336

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled	Canon Medical System USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederl	Potency & Assay