Class I - Dangerous
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
Class I - Dangerous
It has been determined that the software distributed with the retinal camera may delete patient information. Specifically, if multiple IDs are delated at the same time, their is a potential for all patient information to be deleted. This could result in delay of treatment.
Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft).
Remote Diagnostic Technologies
Class I - Dangerous
A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back into manual mode the pacer pulse wave may put the ECG calibration out of calibration. This software error may result in a delay in therapy, as the clinician is not provided an ECG waveform on which a shockable rhythm decision can be made. The device is still able to deliver a manual defibrillation shock.
Class I - Dangerous
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Class I - Dangerous
Two issues were found with the treatment plan report: 1) There may be incorrect information for the percent of a region of interest with a clinical goal that is outside the dose grid; and 2) For RayStation and RayPlan 9B and 10A, 6D couch angles may be incorrect.
Class I - Dangerous
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Class I - Dangerous
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Class I - Dangerous
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
Zimmer Biomet
Class I - Dangerous
Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS Screw System. Users should be aware that changes were made to the contraindications section indicating that the Translation Screws should not be used with a direct current stimulation, as a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation system.
MAC VU360, Electrocardiograph
GE Healthcare
Class I - Dangerous
Incorrect patient identification and/or patient demographic errors.
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
Class I - Dangerous
Potential exposure of product to microbial contamination.
Class I - Dangerous
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
Class I - Dangerous
Potential exposure of product to microbial contamination.
Class I - Dangerous
There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device.
Class I - Dangerous
Potential exposure of product to microbial contamination.
Class I - Dangerous
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead.
WELCH ALLYN, INC/MORTARA
Class I - Dangerous
The radio within the device can become disassociated with the wireless access point.
Class I - Dangerous
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.