Class I - Dangerous
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
Class I - Dangerous
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
A defective rotor yoke on Allegra X-5 allows improper rotor seating on the hub resulting in possible rotor failure if the buckets are loaded in an imbalanced configuration.
A software defect was discovered that causes images to be out of context with clinical information.
Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS 250/350/950/5,1 FS, 4600 Chemistry System or the VITROS 5600 Integrated System. An increase in negatively biased calcium results complaints prompted the investigation that identified this product issue.
Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.
Class I - Dangerous
Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of -37% was observed.
Bayer Healthcare is initiating this recall due to complaints that were received from customer sites describing a 4205 error message when the injector is used with a 3T scanner.
Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.
Class I - Dangerous
An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5. Biological clinical goals for an adapted plan based on another planning CT than the original planning CT will show incorrect values. -- To the best of the firm's knowledge, the issue has not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect plan evaluation during treatment planning.
Class I - Dangerous
A software issue related to the generic volume measurement functionality could result in the volume of the subject anatomy being overestimated. For example, measurement results of the anatomy may appear enlarged or distended when it actually is not.
Eight (8) issues were identified which may affect the results generated by the system software version.
During internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 deletion, T790M) inconsistently generated "No Mutation Detected" (ie False Negative ) result with the cobas EGFR mutation Text V2.0 when utilizing the cobas cfDNA Sample Preparation kit.
Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45 degrees.
Class I - Dangerous
Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].
Class I - Dangerous
Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].
Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the reaction signal over time potentially resulting in the inability to calibrate and use the product.
Class I - Dangerous
Potential for images to be flipped while streaming, which could incorrectly display image orientation markers.
Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect calibration mathematics were assigned to the Calibrator Kit 29 Lots 2915 and 2995 supporting dTIBC Reagent GEN 30 product.
Class I - Dangerous
Medtronic Navigation is recalling certain components of the PoleStar system (N20 / N30) because of misplaced ground pins which may cause electrical shock to the user.