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Electrosurgical generator, esg-410

Official notice

16 Oct 2024

Last checked

16 Oct 2024

Critical riskHealth Canada
Watch Olympus Winter Ibe

An official Health Canada notice concerns Electrosurgical generator, esg-410. Olympus is conducting this medical device recall after identifying an increase in complaints indicating an occurrence of system error e1226 "could not write to audio buffer" during procedures using the ESG-410 (Sep). This error is a high priority alarm which triggers an automatic reboot of the device, which may lead to a delayed or interrupted procedure until the reboot is completed. Rebooting is a safety measure to put the generator back into safe operation. After the reboot, the procedure can be continued. Olympus has developed a software update that prevents this system error e1226 from unnecessarily occurring. Olympus has received six (6) complaints for the ESG-410 (sep) generator with the occurrence of system error e1226. No serious injuries or reportable malfunctions have been reported in relation to this issue. Recall start date: October 1, 2024 Published 2024-10-16.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76340

Official notice

2024-10-16

The hazard

Olympus is conducting this medical device recall after identifying an increase in complaints indicating an occurrence of system error e1226 "could not write to audio buffer" during procedures using the ESG-410 (Sep). This error is a high priority alarm which triggers an automatic reboot of the device, which may lead to a delayed or interrupted procedure until the reboot is completed. Rebooting is a safety measure to put the generator back into safe operation. After the reboot, the procedure can be continued. Olympus has developed a software update that prevents this system error e1226 from unnecessarily occurring. Olympus has received six (6) complaints for the ESG-410 (sep) generator with the occurrence of system error e1226. No serious injuries or reportable malfunctions have been reported in relation to this issue. Recall start date: October 1, 2024

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

76340

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Affected products

Product 1

Affected products - Electrosurgical Generator, ESG-410, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - WA91327U

Risk / hazard

Olympus is conducting this medical device recall after identifying an increase in complaints indicating an occurrence of system error e1226 "could not write to audio buffer" during procedures using the ESG-410 (Sep). This error is a high priority alarm which triggers an automatic reboot of the device, which may lead to a delayed or interrupted procedure until the reboot is completed. Rebooting is a safety measure to put the generator back into safe operation. After the reboot, the procedure can be continued. Olympus has developed a software update that prevents this system error e1226 from unnecessarily occurring. Olympus has received six (6) complaints for the ESG-410 (sep) generator with the occurrence of system error e1226. No serious injuries or reportable malfunctions have been reported in relation to this issue. Recall start date: October 1, 2024

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Olympus Winter Ibe, Electrosurgical Generator Esg-410

Manufacturer

Not provided

Phone

Not provided

Brand: Olympus Winter Ibe, Electrosurgical Generator Esg-410.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

critical

Recall details

Recall number

76340

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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