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.
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Siemens Medical Solutions USA
Class I - Dangerous
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.
LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.
Physio-Control
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
Temperature deviation did not meet release specifications
LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
Physio-Control
Class I - Dangerous
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..
Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5).
Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
Class I - Dangerous
The Bravo Mini (Model 250D), Agilis Mini (Model 250D), and NBP One (Model 250D) are being recalled because of a user safety issue when rechargeable batteries are misused in the product.
Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application
Siemens Medical Solutions USA
Class I - Dangerous
During a routine inspection of a system, a crack on the C-arm holder was discovered. In the event the C-arm holder has a crack, the stability of the C-arm may be compromised and could lead to deformations of the C-arm. In very unlikely cases, an extreme impact to the C-arm such as heavy collision with a wall or table, may lead to a detachment of the C-arm and could potentially result in injury to patients and staff.
Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit that can be used to power the left ventricular assist system, which could lead to no or reduced blood flow from the left ventricular assist system.
Under certain fault conditions, the existing design may expose the operator to a hazardous voltage when contacting the metal enclosure (including mounting screws) around the up/down switch.
Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
Medtronic Navigation, Inc.-Littleton
Class I - Dangerous
Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may loosen over an extended number of uses at a higher frequency in these systems. If the belt loosens, it may result in rotation of 3D images about the gantry isocenter. While the 3D image is anatomically accurate within the image itself and may be used to confirm therapy, its electronic registered location may be rotated relative to the actual physical position of the patient.