- 3015876 LIFEPAK CR2 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results Model Number CR2 Device . With this issue, the device will not be able to connect to the cellular Stryker, in consultation with the Therapeutic Goods Administration, is undertaking a Product Defection Correction to update the operating instructions of all LIFEPAK The LIFEPAK CR2's lid magnet may dislodge from the device. PHYSIO-CONTROL, INC. Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. A further subset of LIFEPAK® CR2 have been identified to have a manufacturing discrepancy that may cause the lid magnet to dislodge from the lid, however none of these devices have been Due to required inspections not being performed on products/units that have gone through servicing. Discontinuation of Product Notice LIFEPAK CR® Plus and LIFEPAK EXPRESS® in United States As Stryker Customer, n authorized distributor, EXPRESS into our automated portfolio, supporting Search Alerts/Recalls PHYSIO-CONTROL, INC. Stryker has initiated a Recall for Product Correction for the operating instructions of all LIFEPAK® CR2 devices. By signing below and returning to Stryker, you have acknowledged that you have received the notification for the Recall for Product Correction involving the LIFEPAK® CR2 Defibrillator and that it Stryker has discovered through customer complaints that some cellular LIFEPAK CR2 devices have incorrect cellular settings. com. Maintaining a State of Readiness (pp. For many years, defibrillators have been used by medical professionals to treat patients in sudden cardiac arrest. A further subset of LIFEPAK® CR2 have been identified to have a manufacturing URGENT MEDICAL DEVICE SAFETY NOTICE AND CORRECTION ACTION REQUIRED Please bring LIFEPAK® CR2 Defibrillator maintaining/monitoring this letter to the Review and complete the attached LIFEPAK CR2 Affected Device List and Acknowledgement Form attached to this notification for the devices related to the lid dimension issue. The Stryker LIFEPAK CR2 is designed for fast, effective response in cardiac emergencies, featuring cprINSIGHT™ technology, WiFi connectivity, and bilingual capabilities to guide rescuers through Class 2 Device Recall LifePak 500 Automatic external DefibrillatorFDA Home Medical Devices Databases The Physio-Control LIFEPAK® CR2 defibrillator combines best-in-class technology with the simplicity and portability required for use by the general public in a Class 2 Device Recall LIFEPAK 15 monitor/defibrillatorFDA Home Medical Devices Databases Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Product part's numbers: 3200731-xxx,3202177-xxx, U3200731 Home Safety Recalls, Market Withdrawals, & Safety Alerts Stryker Launches Voluntary Field Action for Specific Units of the LIFEPAK® 15 Monitor/Defibrillator The best thing you can do to make sure your Physic-Control LIFEPAK CR2 AED is ready to be used whenever you need it is to keep it maintained. - 3015876 LIFEPAK® CR2 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results Physio-Control CR-Plus and Express AED Class 2 Recall Physio-Control LIFEPAK CR Plus and LIFEPAKEXPRESS defibrillators. These 5, easy s Class 2 Device Recall LIFEPAK 500 Automated External Defibrillator (AED)FDA Home Medical Devices Databases LIFEPAK CR2: Adult Mode Fully-Automatic with Ventilations and cprINSIGHT This video shows how to operate a fully-automatic AED on an adult along with 30:2 CPR and cprINSIGHT. The lid magnet is the primary means by which the device will turn on and off when Stryker has initiated a Product Defect Correction for the operating instructions of all LIFEPAK® CR2 devices. Stryker has now become aware that if the lid magnet is missing, it also causes the LIFEPAK CR2 battery to deplete more quickly resulting in premature battery life. LIFEPAK CR2 defibrillator Advanced technology including cprINSIGHT analysis technology, Wi-Fi connectivity and continuous self-monitoring enables AEDs ition LIFENET Readiness will generate Indicator a monthly Please see LIFEPAK CR2 Operating Instructions, instructions. 77- 78) for complete If you Supplemental Operating Instructions Refer to the LIFEPAK CR2 Defibrillator Operating Instructions for complete directions for use. Class 2 Device Recall LIFEPAK 15 Monitor/DefibrillatorFDA Home Medical Devices Databases The LIFEPAK CR2 defibrillator is an automated external defibrillator (AED). Premarket Approval (PMA) FDA Home Medical Devices Databases 510 (k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards CFR Title If you have disposed, transferred or sold any LIFEPAK® CR2 Defibrillators, please immediately let them know of this recall and notify Stryker through email to postmarketssp@stryker.
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