🏥 Medical Devices • 6,554 recalls
Siemens Healthcare Diagnostics
There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support
Siemens Healthcare Diagnostics
There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
Potential to lead to a false negative results.
GE Healthcare
A detector can detach and fall.
Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support
Stryker Sustainability Solutions
Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.
There is a potential for the RadPRO Mobile 40kW Digital X-Ray System Model SM-40HF-B-D-C to separate from the Tube Head Mount and potentially fall off the system.
Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Only specific kits are affected.
The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the keyboard, activate or deactivate the mean pressure waveform display option (On/Off) using the Invasive Pressure Options Dialog or the keyboard, activate or deactivate the waveform hide option (On/Off) using the Invasive Pressure Options Dialog, activate or deactivate the pressure waveform filter option (On/Off) using the keyboard, and/or perform a Pullback using the Pullback icon or the keyboard
Thermal chamber motors have electrical cables with single insulation rather than the required double insulation. There is no exposed current due to the single insulation that could result in a potential electrical shock
Abnormally high INR test results with the affected CoaguChek test strips
Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
The reagent pack exhibits the potential for an increased frequency of calibration failures.
Medtronic Navigation, Inc.-Littleton
O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label; replacing blown fuse of the new AC power input circuit
Synchronization failure
Synchronization failure
Software Correction: Software errors that may result in incorrect 4D CT images, PET images with SUV quantification error, or disruption of interventional CT procedures; and Software errors that may result in partial set of images, inability to generate CT or PET images, incorrect scan parameters, or scanning the incorrect portion of the body.
The product was shipped after its expiry date due to a system error. The product lidstock identifies the correct expiration date however the accompanying purchase order shipping documentation identifies an incorrect expiration date. Per standard clinical practice the lidstock would most likely be checked prior to use and the product would not be used leading to a minor delay while a replacement is located. In the unlikely event that the product lidstock is not checked prior to use, there is potential for use of expired product, and product functionality/or sterility cannot be guaranteed.
Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.