Medical device recall in Canada: Dimension Xpand System software issue
In plain language
This recall involves Dimension Xpand System and Dimension EXL 200 Analyzers sold in Canada. They are being recalled because a software issue prevents users from entering or editing calibration coefficients without manufacturer support. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model/serial numbers if provided.
- Contact Siemens Healthcare Diagnostics Inc. for support.
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Affected products
DIMENSION XPAND SYSTEM - XPAND PLUS BASIC ANALYZER
Model: 765000.921
Lot: 2004081160
DIMENSION XPAND PLUS BASIC ANALYZER - class 2
Model: 765000.921
Lot: 2004081160
DIMENSION EXL 200 ANALYZER
Model: 778041.911
Lot: DE270253
DIMENSION XPAND SYSTEM - XPAND PLUS with hm analyzer - class 2
Model: 765000.931
Lot: 2001081906
DIMENSION XPAND SYSTEM - XPAND PLUS WITH HM ANALYZER
Model: 765000.931
Lot: 2001081906
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: 2001081906, 2004081160, DE270253
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 765000.921, 765000.931, 778041.911
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?
This recall involves Dimension Xpand System and Dimension EXL 200 Analyzers sold in Canada. They are being recalled because a software issue prevents users from entering or editing calibration coefficients without manufacturer support. Stop using the product and follow the return/repair steps in the official notice.
What should consumers do?
Stop using the product immediately. Check model/serial numbers if provided. Contact Siemens Healthcare Diagnostics Inc. for support.
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?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on February 1, 2018.
Is the Dimension brand affected by this recall?
Yes, Dimension products are affected by this recall. This recall involves Dimension Xpand System and Dimension EXL 200 Analyzers sold in Canada. They are being recalled because a software issue prevents users from entering or editing calibration coefficients without manufacturer support. Stop using the product and follow the return/repair steps in the official notice.