Siemens Dimension Software recall in Canada: potential for intermittent failures
In plain language
This recall involves Siemens Dimension Software Version 10.2.2 used in various medical devices sold in Canada. It's being recalled because of potential intermittent failures with the group calibration feature. Healthcare professionals should stop using the affected software and follow the return/repair steps in the official notice.
What to do
- Stop using the affected software immediately.
- Check the model or catalog numbers of your Dimension system.
- Contact Siemens Healthcare Diagnostics Inc. for instructions on how to proceed.
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Affected products
Dimension Xpand System - Xpand Plus Basic Analyzer
Model: 765000.921
Lot: More than 10 numbers, contact manufacturer.
Dimension EXL System - Dimension EXL Analyzer With Loci Module
Model: 759020.911, 778020.911
Lot: More than 10 numbers, contact manufacturer.
Dimension Clinical Chemistry System - RxL Max Analyzer - Class 2
Model: 752000.901, 752000.951
Lot: More than 10 numbers, contact manufacturer.
Dimension Chemistry System - RxL Max Analyzer Class 3
Model: 752000.901, 752000.951
Lot: More than 10 numbers, contact manufacturer.
Dimension EXL System - Dimension EXL Analyzer With LM
Model: 759020.911, 778020.911
Lot: More than 10 numbers, contact manufacturer.
Dimension Xpand Plus Basic Analyzer - Class 2
Model: 765000.921
Lot: More than 10 numbers, contact manufacturer.
Dimension EXL System - Dimension EXL 200 Analyzer
Model: 778041.911
Lot: More than 10 numbers, contact manufacturer.
Dimension Xpand System - Xpand Plus With HM Analyzer - Class 2
Model: 765000.931
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 Chemistry System - 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: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 752000.901, 752000.911, 752000.931-R, 752000.941, 752000.951, 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 Siemens Dimension Software Version 10.2.2 used in various medical devices sold in Canada. It's being recalled because of potential intermittent failures with the group calibration feature. Healthcare professionals should stop using the affected software and follow the return/repair steps in the official notice.
What should consumers do?
Stop using the affected software immediately. Check the model or catalog numbers of your Dimension system. Contact Siemens Healthcare Diagnostics Inc. for instructions on how to proceed.
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 September 7, 2018.
Is the Siemens brand affected by this recall?
Yes, Siemens products are affected by this recall. This recall involves Siemens Dimension Software Version 10.2.2 used in various medical devices sold in Canada. It's being recalled because of potential intermittent failures with the group calibration feature. Healthcare professionals should stop using the affected software and follow the return/repair steps in the official notice.