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
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
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
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
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
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
Class I - Dangerous
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Class I - Dangerous
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Class I - Dangerous
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Lunar iDXA bone densitometer
GE Healthcare
Class I - Dangerous
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
Class I - Dangerous
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
Class I - Dangerous
Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color Secondary Capture (SC) format will archive Diastolic Hyperemia-Free Ratio data as intended. If either Multi-Frame UltraSound (US) or SC Image Storage formats are used, the DFR data will not be archived and the user will not be notified of this unexpected behavior.
T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient to be ambulatory.
WELCH ALLYN, INC/MORTARA
Class I - Dangerous
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
The firm has identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates Reagent Chemistry Information Sheet (CIS). The presence of certain compounds in urine may result in false positive or false negative results.
Class I - Dangerous
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Ortho Clinical Diagnostics
Class I - Dangerous
The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.