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Recall Observatory FDA recall evidence

Device product

Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software Version: Core 15 FHD v1.7 and earlier Product Description: Serialized Monitor

Z-2022-2024

April 29, 2024

Class II

Product summary

Firm
Verathon, Inc.
Event
Event 94547
Status
Ongoing
Classification
Class II
Quantity
1706 devices
Official record key
device-enforcement:Z-2022-2024

Official wording

Reason: Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices.

Code information: Software versions: v1.7 and earlier/UDI/DI: 00879123008596

Distribution pattern: US: AK AL AR AZ CA CO CT DC FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK ON OR PA QLD RI SC SD TN TX UT VA VIC WA WI WV WY OUS: Hong Kong, Indonesia, Saudi Arabia

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices.