🔍 RecallPedia

MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.

Class I - Dangerous
🏥 Medical Devices Recalled: September 12, 2013 Maquet Medical Systems USA Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Part No. 70104.8012 Serial Nos. 90410440; 90410452; 90410455; 90410456; 90410457; 90410459; 90410469; 90410474; 90410480; 904104781; 90410482; 90410484; 90410498; 90410499; 90410500; 90410501; 90410502; 90410503; 90410521; 90410522; 90410524; 90410526; 90410527; 90410531; 90410533; 90410534; 90410535; 90410550; 90410551; 90410552; 90410568; 90410571; 90410572; 90410573; 90410575; 90410576; 90410577; 90410580; 90410581; 90410582; 90410584; 90410585; 90410592; 90410596; 90410599; 90410600; 90410605; 90410606; 90410607; 90410608; 90410609; 90410610; 90410611; 90410612; 90410626; 90410638; 90410640; 90410642; 90410644; 90410646; 90410647; 90410650; 90410651; 90410652; 90410653; 90410656; 90410659; 90410660; 90410661; 90410662; 90410663; 90410664; 90410665; 90410666; 90410667; 90410668; 90410670; 90410700; 90410708; 90410846; 90410750; 90410786
  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:
Maquet Medical Systems USA
Reason for Recall:
It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an error message with audible alarm, indicating "battery defective." The alarm will occur-upon start up or when the main power supply is unplugged from the main power source. The human machine interface touch screen of the CARDIOHELP-i device may gradually become black due to the human machine interface (HMI) back light shutting down.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.

Product Codes/Lot Numbers:

Part No. 70104.8012 Serial Nos. 90410440; 90410452; 90410455; 90410456; 90410457; 90410459; 90410469; 90410474; 90410480; 904104781; 90410482; 90410484; 90410498; 90410499; 90410500; 90410501; 90410502; 90410503; 90410521; 90410522; 90410524; 90410526; 90410527; 90410531; 90410533; 90410534; 90410535; 90410550; 90410551; 90410552; 90410568; 90410571; 90410572; 90410573; 90410575; 90410576; 90410577; 90410580; 90410581; 90410582; 90410584; 90410585; 90410592; 90410596; 90410599; 90410600; 90410605; 90410606; 90410607; 90410608; 90410609; 90410610; 90410611; 90410612; 90410626; 90410638; 90410640; 90410642; 90410644; 90410646; 90410647; 90410650; 90410651; 90410652; 90410653; 90410656; 90410659; 90410660; 90410661; 90410662; 90410663; 90410664; 90410665; 90410666; 90410667; 90410668; 90410670; 90410700; 90410708; 90410846; 90410750; 90410786

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0082-2014

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