Accuray TomoTherapy Treatment System - Product Usage: used as an integrated system for the recall — FDA Z-0784-2021
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
Complete FDA and NHTSA recall records dated in January 2021.
These records include useful source details for the selected month.
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in…
Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances,…
Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances,…
The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in…
Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances,…
The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in…
Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances,…
Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances,…
Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances,…
The cylindrical sponge component is not x-ray detectable.
Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results
Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances,…
The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in…
Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances,…
Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances,…
VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference
Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances,…
Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances,…
Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances,…
Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances,…
Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could lead the Apex HE to thread through the shell of the cup without stopping or to protrude…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.