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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device image processing device for estimation of external blood loss
Definition 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.
Product CodePBZ
Regulation Number 880.2750
Device Class 2


Premarket Reviews
ManufacturerDecision
STRYKER INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 2 2
2023 246 246

Device Problems MDRs with this Device Problem Events in those MDRs
Low Readings 239 239
Incorrect Measurement 5 5
High Readings 3 3
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 248 248

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Corporation II Feb-27-2023
2 Stryker Instruments Div. of Stryker Corporation II Jul-19-2022
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