Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2255-008-01
Zimmer Biomet
Class I - Dangerous
Potential failure of sterile packaging seal.
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
Life Technologies
Class I - Dangerous
The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.
Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length; Item Number: 47-2490-098-00
Zimmer Biomet
Class I - Dangerous
Potential failure of sterile packaging seal.
ZMS Intramedullary Fixation Smooth Guide Wire 2.4 mm Diameter, 100 cm Length; Item Number: 47-2237-033-00
Zimmer Biomet
Class I - Dangerous
Potential failure of sterile packaging seal.
Class I - Dangerous
Potential failure of sterile packaging seal.
Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2490-097-00
Zimmer Biomet
Class I - Dangerous
Potential failure of sterile packaging seal.
Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
Terumo Cardiovascular Systems
Class I - Dangerous
Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation).
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.
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