🏥 Medical Devices • 6,627 recalls
103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect product labels. The tubes were incorrectly labeled as KM169-39-76 Single Diamond Threaded Steinmann Pins.
Siemens Healthcare Diagnostics
On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) for Sodium (Na), Potassium (K), and Chloride (Cl), the system will translate the decimal point separators to commas. This will result in invalid concentration values for the fluids, therefore the system will utilize default nominal values instead of lot specific IMT fluid concentration values for calculation of the calibrations and results for the Na, K, and Cl methods.
It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.
It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.
Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).
It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system s date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.
Polymer Technology Systems
One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.
Siemens Healthcare Diagnostics
Homocysteine Assay May Cause Elevated Results in the Folate Assay
Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis.
Siemens Healthcare Diagnostics
Homocysteine Assay May Cause Elevated Results in the Folate Assay
The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This may lead to a vacuum loss and tubes not filling up to the proper volume.
Siemens Healthcare Diagnostics
Homocysteine Assay May Cause Elevated Results in the Folate Assay
Polymer Technology Systems
One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.
The firm has become aware that the sensor cover, a component of the single-use navigation kit may contain microbial contamination. A source of microbial contamination has been identified in a raw product used to manufacture the tip of the cover.This could result in direct exposure of the intra-cardiovascular, intra-lymphatic or neurological system to a level of endotoxin sufficient to produce a pyrogenic response.
Siemens Medical Solutions USA
The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.
Physio-Control
Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button.
The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet), has changed from sterile 0.85% saline or sterile blood culture media to sterile DI water or pH 7.2 phosphate buffer.
Temperature deviation did not meet release specifications
Physio-Control
Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button.
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..