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B1X5 Software Upgrade

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. · Model V1.5 · UDI-DI 00840682141291

OLW NHQ OLT DPZ CBQ CCL DQA MLD DXN OMC CBR MHX CBS CCK DSJ DQK DSI BZQ ORT DRT FLL KRB NHO GWQ NHP DSK Prescription

510(k) clearances

347

Adverse events (1 deaths)

Recalls

Facilities

Description

B125/B105 V1.5 SW PACK (USB) - MD

Recalls

Date	Firm	Reason
2018-07-26	Covidien LLC	Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.