Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Siemens Medical Solutions USA, Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0782-2020
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