Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

Class I - Dangerous
🏥 Medical Devices Recalled: December 19, 2012 Elekta Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    151055, 151700, 151809, 151695, 151479, 151696, 151867, 151704, 151765, 151860, 151024, 151521, 151803, 152217, 151774, 152220, 151626, 151842, 151847, 151446, 151801, 151953, 151664, 151751, 151352, 151298, 151728, 151504, 151981, 151705, 151977, 152123, 152126, 151955, 105982, 151160, 151634, 151954, 151416, 151074, 151587, 151729, 151694, 151965, 151418, 151674, 151259, 151698, 151699, 152043, 151636, 151811, 151568, 151258, 151584, 151423, 151623, 151627, 151507, 151640, 151933, 151340, 151722, 151810, 151051, 151411, 151360, 151595, 151433, 151611, 152008, 151151, 151714, 151653, 151675, 151538, 152031, 151523, 151519, 151432, 151783, 151410, 151371, 151084, 151387, 151978, 151530, 151328, 151689, 151567, 151598, 151760, 151269, 151557, 151558, 151789, 151398, 151632, 152214, 151301, 151441, 151256, 151391, 151038, 151585, 151327, 151326, 151250, 151130, 151828, 151245, 151672, 105803, 151073, 151956, 152232, 151319, 151959, 151960, 151958, 151435, 151779, 151969, 151848, 151875, 151881, 151882, 151736, 152023, 152080, 152079, 152064, 151734, 151763, 152154, 151110, 151363, 151216, 151173, 151678, 151467, 151961, 151178, 152091, 152051, 152115, 152116, 151708, 152176, 152192, 152098, 152200, 152174, 152246, 152364, 152673, 152425, 151156, 151764, 151886, 151076, 151369, 152175, 105941
  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:
Elekta, Inc.
Reason for Recall:
The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

Product Codes/Lot Numbers:

151055, 151700, 151809, 151695, 151479, 151696, 151867, 151704, 151765, 151860, 151024, 151521, 151803, 152217, 151774, 152220, 151626, 151842, 151847, 151446, 151801, 151953, 151664, 151751, 151352, 151298, 151728, 151504, 151981, 151705, 151977, 152123, 152126, 151955, 105982, 151160, 151634, 151954, 151416, 151074, 151587, 151729, 151694, 151965, 151418, 151674, 151259, 151698, 151699, 152043, 151636, 151811, 151568, 151258, 151584, 151423, 151623, 151627, 151507, 151640, 151933, 151340, 151722, 151810, 151051, 151411, 151360, 151595, 151433, 151611, 152008, 151151, 151714, 151653, 151675, 151538, 152031, 151523, 151519, 151432, 151783, 151410, 151371, 151084, 151387, 151978, 151530, 151328, 151689, 151567, 151598, 151760, 151269, 151557, 151558, 151789, 151398, 151632, 152214, 151301, 151441, 151256, 151391, 151038, 151585, 151327, 151326, 151250, 151130, 151828, 151245, 151672, 105803, 151073, 151956, 152232, 151319, 151959, 151960, 151958, 151435, 151779, 151969, 151848, 151875, 151881, 151882, 151736, 152023, 152080, 152079, 152064, 151734, 151763, 152154, 151110, 151363, 151216, 151173, 151678, 151467, 151961, 151178, 152091, 152051, 152115, 152116, 151708, 152176, 152192, 152098, 152200, 152174, 152246, 152364, 152673, 152425, 151156, 151764, 151886, 151076, 151369, 152175, 105941

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0931-2013

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