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Ultrasonic gastrovideoscope
Official notice
4 Apr 2022
Last checked
4 Apr 2022
An official Health Canada notice concerns Ultrasonic gastrovideoscope. Olympus Medical Systems Corp (OMSC) conducted a postmarket risk assessment of the GFUC140P-AL5. As part of that review, OMSC applied updated FDA guidance for reprocessing validation. OMSC's testing showed that the GF-UC140P-AL5, when reprocessed in the OERPRO, would not meet the current FDA guidance for reprocessing validation without further design changes. An ineffectively reprocessed endoscope can present an infection control risk to patients. As a result, OMSC is revising the OER-PRO labelling such that the GF-UC140PAL5 is no longer a compatible endoscope for reprocessing in the OER-PRO. Olympus has not received any reported complaints of infection associated with the GFUC140P-AL5 when reprocessed in the OER-PRO. Recall start date: Mar 18, 2022 Published 2022-04-04.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64039
Official notice
2022-04-04
The hazard
The hazard
Olympus Medical Systems Corp (OMSC) conducted a postmarket risk assessment of the GFUC140P-AL5. As part of that review, OMSC applied updated FDA guidance for reprocessing validation. OMSC's testing showed that the GF-UC140P-AL5, when reprocessed in the OERPRO, would not meet the current FDA guidance for reprocessing validation without further design changes. An ineffectively reprocessed endoscope can present an infection control risk to patients. As a result, OMSC is revising the OER-PRO labelling such that the GF-UC140PAL5 is no longer a compatible endoscope for reprocessing in the OER-PRO. Olympus has not received any reported complaints of infection associated with the GFUC140P-AL5 when reprocessed in the OER-PRO. Recall start date: Mar 18, 2022
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Olympus Medical, Ultrasonic Gastrovideoscope.
Source & status
Source & status
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Tier
Category
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Recall details
Recall details
Recall number
Classification
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Documents, notices & source
See the official notice and source documents for full details.
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