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When the specific circumstances described below occur, there is a possibility of displaying distorted images along with erroneous measurements. the distortion and measurement difference could affect decisions regarding patient care.…

System overestimates the circumference when the manual trace function is used. the trace circumference value is overestimated; however, the area value is accurate. the issue is present in Sequoia's VA20A/VA25 onward as the VA20A introduced a…

If prior to the IFR/FFR pullback on the intrasight system, FFR measurement(s) were performed within the same syncvision procedural session, the co-registered distal value will be different than the distal value displayed in the philips IFR/FFR system.…

Cardinal Health has initiated a medical device correction for specific production lots of non-absorbent towels due to varying levels of adhesion. Cardinal Health is conducting this correction due to the potential for the non-absorbent towels to have…

The affected vitros CKMB slides coating does not adequately inhibit CK-mm up to a total CK more than 1000 u/L. Therefore, samples with a total CK value less than 1000 u/L may exhibit falsely elevated vitros CKMB slides results. Recall start date: Nov…

Copan has received some reports of Bordetella parapertussis false positives observed at high cycle threshold values (Ct, Cycle threshold) when combining eSwab with some in-house PCR protocols and the Pathofinder BV-RealAccurate Quadruplex Bordetella PCR…

BD has received 13 complaints that the product referenced above has the potential to underfill or exhibit draw volumes below labeled product claims. Underfilling of tubes could result an incorrect additive-to-blood ratio, which could cause erroneous test…

Roche received few complaints from customers reporting the generation of false mutation detected results for the Exon 20 insertion (EX20INS) mutation when using the Cobas EGFR mutation test V2. Recall start date: 2021-09-15…

MRI images with certain values in the Dicom tags rescale slope (0028,1053) and rescale intercept (0028, 1052) can show wrong statistical values 'min/max' (maximum and minimum grayscale value in the ROI) and 'Mean/STD D' (mean value and…

MRI images with certain values in the Dicom tags rescale slope (0028,1053) and rescale intercept (0028, 1052) can show wrong statistical values 'min/max' (maximum and minimum grayscale value in the ROI) and 'Mean/STD D' (mean value and…

Two issues with the diagnostic ultrasound system Arietta 850 (software version V1.0.0 - V4.1.3) Used in combination with a Fujifilm (formally Hitachi) Transducer: (1) the calculation result of eroa is displayed incorrectly when measuring…

Issue 1 - updated calibration data not saved with measurement after scene+/- : after closing and reopening the same scene during review, the previously displayed change of distance measurements is lost, i.E. The image text shows the…

Following an investigation of customer complaints, an increase in curve activity and decrease in top point separation between calibrator (CAL) points 5 and 6 was observed for IK018.S lot 472776 (lK018.L.S lot 435251 shares the same…

During the internal investigation of the non-conformance opened on API 50 CH sequence 40-49 lots #1008352920 and 1008510240 for false positive results on test 49 it was confirmed that test 19 of API 50 CH lot# 1008603700 contains a mix…

Potential to display incomplete patient imaging study in Centricity Universal viewer Zero Footprint (ZFP) configured with a Centricity pacs back end.   Recall date: 2021-10-18