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Recall Observatory FDA recall evidence

Device product

GEM FLOW COUPLER Monitor, PN 5156-00000-011

Z-2208-2023

June 19, 2023

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 92525
Status
Ongoing
Classification
Class II
Quantity
122 units
Official record key
device-enforcement:Z-2208-2023

Official wording

Reason: An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active channel prior to powering down.

Code information: GTIN 00844735006148, all serial numbers

Distribution pattern: US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active channel prior to powering down.