Complete FDA and NHTSA recall records dated in April 2022.
These records include useful source details for the selected month.
There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of…
Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.
Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for the position…
Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling
The finished device package did not contain the IFU.
An incorrect center bolt was used in the assembly of the product which could result in a patient fall during use.
If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control…
An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The…
The Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of a manufacturing issue (failure to apply Loctite adhesive). As a result of the set screw…
Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential for QC failures or erroneous…
Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle…
Product was distributed with incorrect expiration date.
Devices distributed lacked regulatory clearance.
Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B…
An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients.
The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite…
Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling
Product was distributed with incorrect expiration date.
The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite…
The Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of a manufacturing issue (failure to apply Loctite adhesive). As a result of the set screw…
Product was distributed with incorrect expiration date.
The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results.
Undeclared Allergen- Milk
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.
