🔍 RecallPedia

Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.

Class I - Dangerous
🏥 Medical Devices Recalled: April 18, 2022 GE Healthcare Patient Monitors Nationwide

What Should You Do?

  1. Check if you have this product:
    Field Replacement Unit kits PN: 1009-5682-000-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V) and PN: 5856787-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V PAIR).
  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:
GE Healthcare, LLC
Reason for Recall:
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.

Product Codes/Lot Numbers:

Field Replacement Unit kits PN: 1009-5682-000-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V) and PN: 5856787-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V PAIR).

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1227-2022

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