Health Canada Posts Type II Recall of GE SIGNA Architect MR System 2026
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Health Canada has published a Type II health product recall for the SIGNA Architect, a radiology medical device from Ge Medical Systems LLC, over incorrect liver stiffness measures produced by the MR Touch protocol on certain MR systems. The notice went up on 2026-10-16 and is directed at the healthcare audience rather than the general public.
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Recalled Products at a Glance
The recall covers a single product listing. The affected product is the SIGNA Architect, model or catalogue number SIGNA ARCHITECT, carrying the lot or serial number PG75M2300263SC. Health Canada files it under Health products – Medical devices – Radiology.
The listing does not state how many units are involved, and it does not include a UPC or a distribution list. Anyone looking for those details will need to go to the manufacturer.
- Product: SIGNA Architect
- Company: Ge Medical Systems LLC, 3200 North Grandview Blvd, Waukesha, Wisconsin, United States, 53188
- Lot or serial number: PG75M2300263SC
- Recall class: Type II
- Recall date: 2026-10-09
- Published: 2026-10-16
- Identification number: RA-82807
- Issue type: Medical devices – Performance
What Triggered the Recall
Health Canada classifies the problem as a performance issue and describes it as incorrect liver stiffness measures from the MR Touch protocol on certain MR systems. In plain terms, the protocol in question can return liver stiffness values that are not correct on the affected systems.
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The notice is brief. It does not explain the technical cause of the incorrect measures, and it does not say whether any injuries or adverse events have been reported. It also does not describe what the clinical consequences of an incorrect measure could be, so readers should avoid drawing conclusions beyond what the regulator has published.
Who Should Be Concerned
The audience listed for this recall is healthcare. That points to facilities and professionals who operate or rely on the listed system, rather than to people buying a product off a store shelf. Health Canada published the notice, and the company named on it is based in Waukesha, Wisconsin.
Patients who have had a liver stiffness measurement taken with an MR system and have questions about their results should raise them with the healthcare provider who ordered the scan. The recall notice itself does not address patients directly and does not recommend re-testing.
What Consumers Need to Do Now
The only action Health Canada lists is to contact the manufacturer if you require additional information. Beyond that, a few practical steps follow from the details in the notice:
- Check whether your system matches the SIGNA Architect model with lot or serial number PG75M2300263SC.
- Contact Ge Medical Systems LLC for further information about the recall and about the MR Touch protocol on your system.
- Review the original Health Canada notice under identification number RA-82807 for any updates.
- Report any health or safety concern to Health Canada using the reporting link on the recall page.
Regulatory Response
Health Canada lists this as a Type II health product recall with a recall date of 2026-10-09 and an original published date of 2026-10-16. The notice carries the identification number RA-82807 and was issued by Health Canada in its medical devices area.
Health Canada also offers email notifications for new and updated recalls and safety alerts. Healthcare facilities that want to follow changes to this notice can subscribe through the recall and safety alerts site.
Because the published notice is short, further details may follow. Readers should treat the Health Canada page as the authoritative source and check it again for any changes to the recall.
Official Source: View original notice on Health Canada →
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