Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
🔬
Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Class I - Dangerous
Intermittent communication due to inconsistent crimping of connectors onto cables.
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Class I - Dangerous
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Class I - Dangerous
Inability for the guidewire to pass through the needles included with the catheter kits.
Class I - Dangerous
When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If this happens, live parts may be exposed (230 V) and/or the video signal can be lost.
Class I - Dangerous
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Class I - Dangerous
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Class I - Dangerous
False positive reaction on the reagent.
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Class I - Dangerous
Inability for the guidewire to pass through the needles included with the catheter kits.
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Class I - Dangerous
Inability for the guidewire to pass through the needles included with the catheter kits.
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Class I - Dangerous
Inability for the guidewire to pass through the needles included with the catheter kits.
Class I - Dangerous
Inability for the guidewire to pass through the needles included with the catheter kits.
Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
Siemens Medical Solutions USA
Class I - Dangerous
Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305 / 80, the unplugging of the main cable can cause an unsafe electrical voltage (125 V DC) at the X10 connector and result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. These contact pins are accessible when the main cable is unplugged from the X10 connector
Class I - Dangerous
Inability for the guidewire to pass through the needles included with the catheter kits.
Firm identified software issues which leads to the patient ID and patient information not being stored in the system.
Class I - Dangerous
The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of the transducer. This issue may result in affected transducers not initiating auto-cool during use which could result in patient injury