Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
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.
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.
Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.
Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
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.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.
If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automatic reduction of speed, a software defect could potentially lead the collimator to collide with patient shoulders or the patient table.
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
Potential for device to overheat during operation f the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.
Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range.