🔍 RecallPedia

Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

Class I - Dangerous
🏥 Medical Devices Recalled: December 27, 2016 Villa Sistemi Medicali S.P.A. Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    08090531 09090591 10040680 15051450 11020798
  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:
Villa Sistemi Medicali S.P.A.
Reason for Recall:
Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

Product Codes/Lot Numbers:

08090531 09090591 10040680 15051450 11020798

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1429-2017

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Villa Sistemi Medicali S.P.A.

Class I - Dangerous

An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.

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