🔍 RecallPedia

Capnostream20 (US)M REFURBISHED, Part Number CS78653

Class I - Dangerous
🏥 Medical Devices Recalled: July 31, 2018 Oridion Medical 1987 Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    B300001025 B300001053 B300001106 B300001109 B300001140 B300001178 B300001219 B300001282 B300001304 B300001324 B300001262 B300001094 B300001177 B300001208 B300001242 B300001246 B300001313 B500002196 B300001188 B300001236 B300002173 B500002408 B300001071 B300001075 B300001124 B300001204 B300001248 B300001443 B500001655 B500001659 B500001660 B500001666 B500001670 B500001683 B500001701 B500001806 B500001817 B500002130 B500002189 B500002231 B300001066 B300001244 B300001207
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Oridion Medical 1987 Ltd.
Reason for Recall:
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Capnostream20 (US)M REFURBISHED, Part Number CS78653

Product Codes/Lot Numbers:

B300001025 B300001053 B300001106 B300001109 B300001140 B300001178 B300001219 B300001282 B300001304 B300001324 B300001262 B300001094 B300001177 B300001208 B300001242 B300001246 B300001313 B500002196 B300001188 B300001236 B300002173 B500002408 B300001071 B300001075 B300001124 B300001204 B300001248 B300001443 B500001655 B500001659 B500001660 B500001666 B500001670 B500001683 B500001701 B500001806 B500001817 B500002130 B500002189 B500002231 B300001066 B300001244 B300001207

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0033-2019

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Oridion Medical 1987

Class I - Dangerous

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