Biograph 6 - Main Unit and Biograph LSO 16 Slice PET (2018-05-16)
In plain language
This recall involves Biograph 6 - Main Unit and Biograph LSO 16 Slice PET systems sold in Canada. They are being recalled because an issue with the CARE Dose4D algorithm could lead to an increased radiation dose during head CT scans. Healthcare professionals should stop using the affected settings and follow the instructions provided by Siemens.
What to do
- Stop using the CARE Dose4D algorithm for head CT scans with Posterior-Anterior (PA) or Anterior Posterior (AP) topograms.
- Follow the instructions provided in the customer letter from Siemens.
- Contact Siemens Medical Solutions for further guidance.
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Affected products
Biograph 6 - Main Unit
Model: 87 28 854
Lot: 44911
Biograph LSO 16 Slice PET
Model: 87 28 581
Lot: 1052 1313 1317 1402 48450 P0007130-0401006 P0007130-0401008
Why this matters
Increased radiation dose
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: 1052 1313 1317 1402 48450 P0007130-0401006 P0007130-0401008, 44911
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 87 28 581, 87 28 854
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Increased radiation dose
What should consumers do?
Stop using the CARE Dose4D algorithm for head CT scans with Posterior-Anterior (PA) or Anterior Posterior (AP) topograms. Follow the instructions provided in the customer letter from Siemens. Contact Siemens Medical Solutions for further guidance.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Increased radiation dose
When was this product recalled?
This product was recalled on June 22, 2018.
Is the Biograph brand affected by this recall?
Yes, Biograph products are affected by this recall. This recall involves Biograph 6 - Main Unit and Biograph LSO 16 Slice PET systems sold in Canada. They are being recalled because an issue with the CARE Dose4D algorithm could lead to an increased radiation dose during head CT scans. Healthcare professionals should stop using the affected settings and follow the instructions provided by Siemens.