Class I - Dangerous
The cutting edge of tissue punches may be potentially damaged with small dents and nicks.
ðĨ
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
OraSure Technologies
Class I - Dangerous
The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
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.
Class I - Dangerous
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
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.
Class I - Dangerous
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected goods could end up falling to the floor causing risk to nearby users and damage to goods and equipment.
Potential risk for helium gas inside the MR examination room during a magnet quench
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
ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Siemens Medical Solutions USA
Class I - Dangerous
Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Siemens Medical Solutions USA
Class I - Dangerous
Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
This device was mislabeled and is not the correct component for this patient.
Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding.
Class I - Dangerous
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;
Carefusion 2200
Class I - Dangerous
The integrity of the sterile packaging is potentially compromised.
Manometer, 550 ml three-Way Stopcock; STERILE;
Carefusion 2200
Class I - Dangerous
The integrity of the sterile packaging is potentially compromised.
WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm, REF415101115R
Wright Medical Technology
Class I - Dangerous
Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.
ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Siemens Medical Solutions USA
Class I - Dangerous
Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.