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U.S. Department of Health and Human Services

Class 2 Device Recall Cios Alpha

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 Class 2 Device Recall Cios Alphasee related information
Date Initiated by FirmNovember 25, 2019
Date PostedJanuary 07, 2020
Recall Status1 Terminated 3 on May 06, 2020
Recall NumberZ-0782-2020
Recall Event ID 84433
510(K)NumberK132094 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductCios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application
Code Information 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 
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactMeredith Adams
610-448-6705
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAn Urgent Medical Device Correction notification letter dated 11/25/19 was sent to customers. How will the corrective action be implemented and what is the efficiency of the corrective actions? To verify that your system is not affected by this problem, a visual inspection will be carried out by trained service staff. If no crack is found during the visual inspection, the C-arm can be used again in its original functionality in patient operation. Should a non-conformity be found and require repair, your device will be sent to the manufacturer and an equivalent loan device will be provided to you at no cost for the duration of the necessary repairs. Following the repair, the C-arm can be used again in its original functionality. Our service organization will contact you shortly to arrange a date to perform this corrective action. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. We thank you for your cooperation, and request that you promptly notify and instruct accordingly all the staff at your organization who need to be aware of this notice and will comply with the recommendations therein. Please ensure that this safety advisory is retained in your product related records appropriately. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. If the device has been sold and is therefore no longer in your possession, please forward this notice to the new owner. We would also request you to inform us of the identity of the device's new owner where possible. Please forward this safety information to any other organizations that could be affected by this measure.
Quantity in Commerce190 (updated total of 202 as of 1/20/20)
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OWB
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