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.
🔬
Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
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.
Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit.
Medtronic Navigation O-arm 02 surgical x-ray imaging system
Medtronic Navigation, Inc.-Littleton
Class I - Dangerous
Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be provided to users in 21CFR part 1 020.30(h).
A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System.
Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028
Medtronic Navigation, Inc.-Littleton
Class I - Dangerous
It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.
Class I - Dangerous
To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice.
Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore Radiology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Philips Medical Systems (Cleveland)
Class I - Dangerous
Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainless steel rather than the specified alloy steel.
Class I - Dangerous
A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110.