Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of packaging integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross microcatheters. A potential for surface contamination on aged catheters was observed during in-house testing.
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Integra determined there is a possibility that the Base Units may break during use.
GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries that have occurred with the use of the device.
Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.
Mindray DS USA, Inc. d.b.a. Mindray North America
Class I - Dangerous
Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for detecting cardiac arrhythmia.
Class I - Dangerous
Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, or from Roche's Accu-Chek Advantage 03 and 04 meters to healthcare professionals.
Class I - Dangerous
GE has become aware of multiple issues affecting the Dash 3000/4000/5000 and DashPort 2 monitor. This report of correction encompasses the DashPort 2 device, in which the DashPort 2 stops communicating with the Dash, resulting in Loss of Monitoring at the CIC. The DashPort 2 status LEDs in the back of the unit indicate Unity Network and DashPort 2 to Dash communication has stopped.
Class I - Dangerous
Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis.
The firm is recalling the products due to a potential for false negative test results.