Medical device recall in Canada: Dimension Xpand System
In plain language
This recall involves several Dimension medical analyzer systems sold in Canada, including the Dimension Xpand System - Xpand Plus and Dimension EXL Analyzer with LM. The recall is due to software behaviors that are inconsistent with expectations. These behaviors do not impact the accuracy of patient results and will be corrected in a future software version.
What to do
- Stop using the product immediately.
- Check model and serial numbers if provided.
- Contact Siemens Healthcare Diagnostics for further instructions.
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Affected products
Dimension Xpand System - Xpand Plus
Model: 765000.921
Lot: 2004080889, 2004081061, 2004081160
Dimension EXL Analyzer with LM
Model: 759020.911, 778020.911
Lot: 12251747, 12251791, 12251797, 12251965, 12252005, 12252027, 12252113, 12252114, 12252139, 12252422, 12252429, 12252468, 12252520, 12252523, 12252559, 12252622, 12252682, 12252687, 12252762, 12252786, 12252790, 12252818, DR250262
Dimension EXL 200 Analyzer
Model: 778041.911
Lot: More than 10 numbers, contact manufacturer.
Dimension Xpand System - Xpand Plus with HM Analyzer
Model: 765000.931
Lot: More than 10 numbers, contact manufacturer.
Dimension RXL Max W/HM Analyzer
Model: 752000.911, 752000.931-R, 752000.941
Lot: More than 10 numbers, contact manufacturer.
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: 12251747, 12251791, 12251797, 12251965, 12252005, 12252027, 12252113, 12252114, 12252139, 12252422, 12252429, 12252468, 12252520, 12252523, 12252559, 12252622, 12252682, 12252687, 12252762, 12252786, 12252790, 12252818, DR250262, 2004080889, 2004081061, 2004081160, More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 752000.911, 752000.931-R, 752000.941, 759020.911, 765000.921, 765000.931, 778020.911, 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 several Dimension medical analyzer systems sold in Canada, including the Dimension Xpand System - Xpand Plus and Dimension EXL Analyzer with LM. The recall is due to software behaviors that are inconsistent with expectations. These behaviors do not impact the accuracy of patient results and will be corrected in a future software version.
What should consumers do?
Stop using the product immediately. Check model and serial numbers if provided. Contact Siemens Healthcare Diagnostics for further instructions.
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 May 3, 2019.
Is the Dimension brand affected by this recall?
Yes, Dimension products are affected by this recall. This recall involves several Dimension medical analyzer systems sold in Canada, including the Dimension Xpand System - Xpand Plus and Dimension EXL Analyzer with LM. The recall is due to software behaviors that are inconsistent with expectations. These behaviors do not impact the accuracy of patient results and will be corrected in a future software version.