DISCOVERY MR750 MR SYSTEM, DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING SYSTEM, SIGNA HDXT 1.5T MR SYSTEM, DISCOVERY MR450 1.5T MR SYSTEM (2021-06-16)
In plain language
This recall involves several GE Medical Systems MR Systems used in Canada. They are being recalled because a software issue could lead to incorrectly annotated or flipped images. This could potentially result in improper medical treatment.
What to do
- Stop using the product immediately.
- Check model and serial numbers if provided.
- Follow the return/repair steps in the official notice.
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Affected products
DISCOVERY MR750 MR SYSTEM - MAIN UNIT
Model: DISCOVERY MR750 3.0T
Lot: 416595MR1, 514848MR1, 519685MR3T, 604875MR750, 902473MR2, 905522MR3T
SIGNA HDXT 1.5T MR SYSTEM - MAIN UNIT
Model: 1.5T SIGNA HDXT MR SYSTEM, KWMRIHDXT
Lot: 514473MR1
DISCOVERY MR450 1.5T MR SYSTEM - MAIN UNIT
Model: DISCOVERY MR450 1.5T MR SYSTEM
Lot: 250727MR2, 403541MR1
OPTIMA MR450W MRI SYSTEM - MAIN UNIT - 16CH
Model: OPTIMA MR450W 1.5T
Lot: 416212MR450, 450466MR1, 514697MR450, 902893MR1
OPTIMA MR450W MRI SYSTEM - MAIN UNIT - 32CH
Model: M7004ZJ
Lot: 403670MR1, 613938MR1, 780532MR1
OPTIMA MR450W MRI SYSTEM - MAIN UNIT - GEM
Model: M7000YN
Lot: More than 10 numbers, contact manufacturer.
DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING SYSTEM - MAIN UNIT
Model: DISCOVERY MR750W 3.0T
Lot: 506648MR4, 613737MR1
SIGNA PET/MR
Model: SIGNA PET/MR
Lot: 604822MRP1
SIGNA PIONEER
Model: SIGNA PIONEER
Lot: 250598MR1, 403253MR1
SIGNA ARCHITECT
Model: SIGNA ARCHITECT
Lot: 403777SIGNA3T, 604582MR750, 780699MR3T, 905527MR1, E416249MR2
SIGNA PREMIER
Model: SIGNA PREMIER
Lot: 514934MR4
Why this matters
Risk of improper medical treatment
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: 250598MR1, 403253MR1, 250727MR2, 403541MR1, 403670MR1, 613938MR1, 780532MR1, 403777SIGNA3T, 604582MR750, 780699MR3T, 905527MR1, E416249MR2, 416212MR450, 450466MR1, 514697MR450, 902893MR1, 416595MR1, 514848MR1, 519685MR3T, 604875MR750, 902473MR2, 905522MR3T, 506648MR4, 613737MR1, 514473MR1, 514934MR4, 604822MRP1, More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 1.5T SIGNA HDXT MR SYSTEM, DISCOVERY MR450 1.5T MR SYSTEM, DISCOVERY MR750 3.0T, DISCOVERY MR750W 3.0T, KWMRIHDXT, M7000YN, M7004ZJ, OPTIMA MR450W 1.5T, SIGNA ARCHITECT, SIGNA PET/MR, SIGNA PIONEER, SIGNA PREMIER
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?
Risk of improper medical treatment
What should consumers do?
Stop using the product immediately. Check model and serial numbers if provided. Follow the return/repair steps in the official notice.
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. Risk of improper medical treatment
When was this product recalled?
This product was recalled on June 30, 2021.
Is the GE Medical Systems brand affected by this recall?
Yes, GE Medical Systems products are affected by this recall. This recall involves several GE Medical Systems MR Systems used in Canada. They are being recalled because a software issue could lead to incorrectly annotated or flipped images. This could potentially result in improper medical treatment.