183 recalls tagged with “elderly product”.
It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Product may be contaminated with Listeria monocytogenes.
Lack of Assurance of Sterility
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Siemens Medical Solutions USA recalled 71 MAGNETOM Lumina MRI systems worldwide, including US and 50+ countries, due to ice blockage in the magnet venting system that could cause a helium leak during a quench.
Potential contamination with Listeria monocytogenes
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.