Complete FDA and NHTSA recall records dated in July 2019.
These records include useful source details for the selected month.
There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot…
The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot…
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot…
User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling repeat testing requests/results properly and may contribute to transmitting erroneous…
Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.
When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot…
The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot…
There is a potential for the device to fail to deliver energy to the patient.
There is a potential for weak seals of the sterile packaging.
The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the system. If a charger board is not functioning properly, the batteries will not receive a full…
There is a potential for weak seals of the sterile packaging.
A steady upward trend in blank (u) absorbance was observed
The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
There is a potential for weak seals of the sterile packaging.
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
Wheat is not declared as an ingredient or allergen.
Product tested positive for Listeria monocytogenes.
Washington State Department of Agriculture sampled and tested frozen avocado and found Listeria monocytogenes.
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.
