Image Processing Device For Estimation Of External Blood Loss
General Hospital · 21 CFR 880.2750
An image processing device for estimation of external blood loss is a device to be used as an aid in estimation of patient external blood loss. The device may include software and/or hardware that is used to process images capturing externally lost blood to estimate the hemoglobin mass and/or the blood volume present in the images.
Recent MDR events
268 adverse event reports on file
- SC+ AI SOFTWAREJul 22, 2026MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2026-99394
- SURGICAL TABLET 3.0Apr 22, 2026MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2026-99221
- TRITON AI SOFTWAREApr 22, 2026MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2026-99319
- TRITON AI SOFTWAREJan 23, 2026MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2026-99040
- SC+ AI SOFTWAREJan 23, 2026MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2026-99121
- TRITON AI SOFTWAREOct 28, 2025MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2025-99408
- SURGICAL TABLET 3.0Jul 29, 2025MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2025-99148
- TRITON AI SOFTWAREApr 15, 2025MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2025-00627
- TRITON CANISTERApr 15, 2025MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2025-00625
- SURGICAL TABLET 3.0Jan 6, 2025MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2025-00019
Event type breakdown
Most-reported manufacturers
Recalls
4 recall events for this product code
- Stryker CorporationOpen, ClassifiedFeb 27, 2023
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.
Z-1184-2023 · View FDA record ↗ - Stryker CorporationOpen, ClassifiedFeb 27, 2023
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.
Z-1185-2023 · View FDA record ↗ - Stryker CorporationOpen, ClassifiedFeb 27, 2023
Triton Canister Software
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.
Z-1186-2023 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedUnknown
Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A softwa
Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels may result in lower than expected results.
Z-1402-2022 · View FDA record ↗
Registered firms
6 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- Stryker InstrumentsMar 16, 2026
K252282 · SurgiCount+ System
- Stryker InstrumentsJan 11, 2024
K232250 · SurgiCount+ System
- Gauss Surgical, Inc.,Apr 25, 2017
K163507 · Triton Sponge System
- Gauss Surgical, Inc.,Aug 5, 2016
K160338 · Triton System
- Gauss Surgical, Inc.,Mar 12, 2015
K142801 · Triton Canister System
- Gauss Surgical, Inc.,May 9, 2014
DEN130015 · PIXEL 3 SYSTEM