BIOGRAPH MCT recall in Canada: patient fall hazard
In plain language
This recall involves several models of BIOGRAPH MCT medical devices sold in Canada. It's being recalled because improper use of the PHS pallet/foot extension could lead to patient falls. Healthcare providers should ensure proper assembly and use of the extension as instructed in the operator's manual.
What to do
- Stop using the product immediately if not properly trained.
- Ensure proper operator assembly of the PHS pallet/foot extension.
- Only use the PHS pallet/foot extension for its intended purpose of feet-first imaging.
- Contact the manufacturer for additional information.
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Affected products
BIOGRAPH MCT-S WITH TRUE V (64)
Model: 10248672
Lot: 11030
BIOGRAPH MCT-S (40)
Model: 10248668
Lot: 60029
BIOGRAPH MCT-S WITH TRUE V (40)
Model: 10248671
Lot: 11058, 11069, 60036
BIOGRAPH MCT FLOW-3R
Model: 10528956
Lot: 59002
BIOGRAPH MCT FLOW-4R
Model: 10529159, 10529161
Lot: 11002, 11010, 60036
BIOGRAPH MCT FLOW EDGE-4R
Model: 10528955
Lot: 11013
BIOGRAPH MCT-S (20)
Model: 10534160
Lot: 91147
BIOGRAPH HORIZON - 3R
Model: 10532746
Lot: 94759
BIOGRAPH VISION
Model: 10749670, 10749672
Lot: 11032, 11038, 11042, 11044, 11048, 11064, 11079
Why this matters
Patient fall hazard
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: 11002, 11010, 60036, 11013, 11030, 11032, 11038, 11042, 11044, 11048, 11064, 11079, 11058, 11069, 60036, 59002, 60029, 91147, 94759
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 10248668, 10248671, 10248672, 10528955, 10528956, 10529159, 10529161, 10532746, 10534160, 10749670, 10749672
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?
Patient fall hazard
What should consumers do?
Stop using the product immediately if not properly trained. Ensure proper operator assembly of the PHS pallet/foot extension. Only use the PHS pallet/foot extension for its intended purpose of feet-first imaging. Contact the manufacturer for additional information.
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. Patient fall hazard
When was this product recalled?
This product was recalled on November 26, 2021.
Is the SIEMENS MEDICAL SOLUTIONS USA, INC. MOLECULAR IMAGING brand affected by this recall?
Yes, SIEMENS MEDICAL SOLUTIONS USA, INC. MOLECULAR IMAGING products are affected by this recall. This recall involves several models of BIOGRAPH MCT medical devices sold in Canada. It's being recalled because improper use of the PHS pallet/foot extension could lead to patient falls. Healthcare providers should ensure proper assembly and use of the extension as instructed in the operator's manual.