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Image Processing Device For Estimation Of External Blood Loss

FDA product code PBZ · Class 2 · General Hospital

21
Registered devices
268
Adverse events
4
Recalls
6
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2023-01-25Stryker CorporationTriton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could
2023-01-25Stryker CorporationTriton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could
2023-01-25Stryker CorporationTriton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could
2020-01-22Stryker Instruments Div. of Stryker CorporationSome Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtain

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.