🔍 RecallPedia

IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.

Class I - Dangerous
🏥 Medical Devices Recalled: March 4, 2016 Philips Medical Systems (Cleveland) Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    M/N 881001; S/N: 85254, 82202, 85330, 82117, 7000022, 105009, 970001, 850001, 870030, 82141, 95068, 87182, 87197, 95078, 82140, 11017, 98139, 95035, 87200, 980047, 85314, 85303, 980046, 85298, 822022, 7000019, 950076, 950115, 95043, 95047, 950021, 960123 & 105006.
  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:
Philips Medical Systems (Cleveland) Inc
Reason for Recall:
The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.

Product Codes/Lot Numbers:

M/N 881001; S/N: 85254, 82202, 85330, 82117, 7000022, 105009, 970001, 850001, 870030, 82141, 95068, 87182, 87197, 95078, 82140, 11017, 98139, 95035, 87200, 980047, 85314, 85303, 980046, 85298, 822022, 7000019, 950076, 950115, 95043, 95047, 950021, 960123 & 105006.

Distribution:

Distributed in: US, CO, DE, FL, GA, IL, IN, KS, MO, NC, NV, NY, OH, OR, PA, TN, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1506-2016

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