🔍 RecallPedia

Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Class I - Dangerous
🏥 Medical Devices Recalled: March 24, 2016 Philips Medical Systems (Cleveland) Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model #: 728246; Serial #s: 3010, 3017, 3031, 3040, 3043, 3070, 3072, 3085, 3090, 3117, 3123, 3149, 3179, 3216, 3247, 3293, 3314, 3324, 3411, 3465, 3490, 5006, 5009, 5012, 5018, 5020, 5024, 5026, 5028, 5030, 5031, 5035, 5044, 5045, 5048, 5052, 5053, 5054, 5055, 5058, 5059, 5060, 5064, 5069, 5070, 5075, 5077, 5081, 5086, 5088, 5091, 5093, 5097, 5099, 5101, 5103, 5107, 5108, 5110, 5111, 5113, 5115, 5116, 5118, 5120, 5123, 5126, 5127, 5128, 5131, 5135, 5138, 5140, 5147, 5155, 5160, 5161, 5163, 5166, 5181, 5184, 5186, 5188, 5190, 5191, 5192, 5193, 5195, 5197, 5208, 5209, 5216, 5219, 5224, 5231, 5235, 5236, 5237, 5270, 5272, 5279, 5282, 5285, 5287, 5288, 5294, 5295, 5315, 5316, 5347, 5348, 5350, 5354, 5357, 5360, 5368, 5394, 5405, 5412, 5433, 5434, 5443, 5453, 5457, 5474, 5480, 5487, 5501, 5502, 5505, 5516, 5519, 5523, 5526, 5554, 5572, 5573, 5576, 5609, 5615, 5633, 5647, 5653, 5674, 5683, 5703, 5723, 5758, 5762, 5764, 5771, 5811, 5897, 5929, 5937, 5956, 5974, 5995, 6021, 6022, 6031, 6033, 6048, 6053, 6072, 6154, 6220, 6229, 6243, 6280, 6283, 6298, 6299, 6309, 6321, 6360, 6375, 6405, 6426, 6441, 6465, 6474, 6484, 6492, 6503, 6511, 6517, 6519, 6523, 6549, 6555, 6559, 30011, 30049, 30110, 32287, 32366, 50011, 50053, 50087, 50180, 50181, 5238A.
  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:
Software defect causing intermittently slow response of Host.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Product Codes/Lot Numbers:

Model #: 728246; Serial #s: 3010, 3017, 3031, 3040, 3043, 3070, 3072, 3085, 3090, 3117, 3123, 3149, 3179, 3216, 3247, 3293, 3314, 3324, 3411, 3465, 3490, 5006, 5009, 5012, 5018, 5020, 5024, 5026, 5028, 5030, 5031, 5035, 5044, 5045, 5048, 5052, 5053, 5054, 5055, 5058, 5059, 5060, 5064, 5069, 5070, 5075, 5077, 5081, 5086, 5088, 5091, 5093, 5097, 5099, 5101, 5103, 5107, 5108, 5110, 5111, 5113, 5115, 5116, 5118, 5120, 5123, 5126, 5127, 5128, 5131, 5135, 5138, 5140, 5147, 5155, 5160, 5161, 5163, 5166, 5181, 5184, 5186, 5188, 5190, 5191, 5192, 5193, 5195, 5197, 5208, 5209, 5216, 5219, 5224, 5231, 5235, 5236, 5237, 5270, 5272, 5279, 5282, 5285, 5287, 5288, 5294, 5295, 5315, 5316, 5347, 5348, 5350, 5354, 5357, 5360, 5368, 5394, 5405, 5412, 5433, 5434, 5443, 5453, 5457, 5474, 5480, 5487, 5501, 5502, 5505, 5516, 5519, 5523, 5526, 5554, 5572, 5573, 5576, 5609, 5615, 5633, 5647, 5653, 5674, 5683, 5703, 5723, 5758, 5762, 5764, 5771, 5811, 5897, 5929, 5937, 5956, 5974, 5995, 6021, 6022, 6031, 6033, 6048, 6053, 6072, 6154, 6220, 6229, 6243, 6280, 6283, 6298, 6299, 6309, 6321, 6360, 6375, 6405, 6426, 6441, 6465, 6474, 6484, 6492, 6503, 6511, 6517, 6519, 6523, 6549, 6555, 6559, 30011, 30049, 30110, 32287, 32366, 50011, 50053, 50087, 50180, 50181, 5238A.

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2369-2016

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Class I - Dangerous

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