Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05 recall — FDA Z-2050-2023
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
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The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument
Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the field by Medtronic Field…
When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail unexpectedly. If this happens, the motor on the power assist device continues to…
It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could…
The firm discovered through customer complaints that device segments may not meet specifications.
There is a software login in issue that may prevent the user from logging in.
The firm discovered through customer complaints that device segments may not meet specifications.
Reagent lot numbers include an insufficient concentration of blocking reagent.
The firm discovered through customer complaints that device segments may not meet specifications.
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
There is a software login in issue that may prevent the user from logging in.
Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive…
It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could…
A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the…
A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive…
A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two…
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be…
Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium…
Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be…
The firm discovered through customer complaints that device segments may not meet specifications.
Devices were imported with Japanese Language and NIST Oxygen Gas Fittings and retrofitted, may pose a serious health risk as the gas pathway of these devices may be contaminated.
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