Medical equipment, implants, and diagnostic devices
Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exceeded the limit for acceptability.
The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury
Medtronic Neuromodulation
Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion.
Ethicon Sarl, a Johnson & Johnson Company
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
Baxter Healthcare
Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury
American Contract Systems
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
We have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050) when connected to the ETH0 slot of either the MNA-6x0 ENC HDMI or MNA-4x0 ENC HDMI. In some instances, this connection may render the first HDMI channel inaccessible, making both the channel and the respective MNA ENC unit unusable. Additionally, readings from the module become unavailable when this issue arises. Similarly, when this Molex module is connected to the ETH0 slot of an MNA-620 ENC ANA, readings may also become inaccessible.
American Contract Systems
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
American Contract Systems
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
Getinge Usa Sales
The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. This issue poses a risk of inadequate charging and operational failure.
American Contract Systems
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue.
American Contract Systems
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
Contact lenses recalled due to potential bacterial contamination.
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.