Class I - Dangerous
There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length; Item Number: 47-2490-098-01
Zimmer Biomet
Class I - Dangerous
Potential failure of sterile packaging seal.
Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .
Terumo Cardiovascular Systems
Class I - Dangerous
Update to cooler-heater cleaning instructions.
T5-NT, Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Philips Electronics North America
Class I - Dangerous
Potential risk for helium gas inside the MR examination room during a magnet quench
Class I - Dangerous
Potential risk for helium gas inside the MR examination room during a magnet quench
Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Philips Electronics North America
Class I - Dangerous
Potential risk for helium gas inside the MR examination room during a magnet quench
Potential risk for helium gas inside the MR examination room during a magnet quench
Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
Angiodynamics Inc. (Navilyst Medical Inc.)
Class I - Dangerous
NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in accordance with specification, and prevents the device from being used, resulting in a minor delay in procedure.
T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Philips Electronics North America
Class I - Dangerous
Potential risk for helium gas inside the MR examination room during a magnet quench
Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Philips Electronics North America
Class I - Dangerous
Potential risk for helium gas inside the MR examination room during a magnet quench
Panorama 1.0T, Model 781250 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Philips Electronics North America
Class I - Dangerous
Potential risk for helium gas inside the MR examination room during a magnet quench
Class I - Dangerous
Potential risk for helium gas inside the MR examination room during a magnet quench
Ingenia 1.5T CX, Models 781261 & 781262 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Philips Electronics North America
Class I - Dangerous
Potential risk for helium gas inside the MR examination room during a magnet quench
Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Philips Electronics North America
Class I - Dangerous
Potential risk for helium gas inside the MR examination room during a magnet quench
Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.
Teleflex Medical Europe
Class I - Dangerous
These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient.
Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature .
Terumo Cardiovascular Systems
Class I - Dangerous
Update to cooler-heater cleaning instructions.
The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.
T5 Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Philips Electronics North America
Class I - Dangerous
Potential risk for helium gas inside the MR examination room during a magnet quench
Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding.
Manometer, 550 ml three-Way Stopcock; STERILE;
Carefusion 2200
Class I - Dangerous
The integrity of the sterile packaging is potentially compromised.