Datascope Corp Recalls
Showing 1-11 of 11 recalls
Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump, Datascope Corp. Mahwah, NJ 07430
Defective Circuit Board -- A defect in the Printed Circuit Board's (PCB) in the CS 100 and CS300 Intra-Aortic Balloon Pump may cause the pump to exhibit intermittent malfunctions, which include failure to start-up or reset of the display screen during therapy.
Datascope sent a Product Field Correction notification letters to Hospital Administrators, via certified mail, on November 19, 2007. The letter informed them of a defect in the circuit board. It described the possible malfunction and provided instructions should malfunctioning occur. Datascope will be replacing the defective circuit boards in all affected IABP units. A Service Representative will be contacting the hospital to arrange for the replacement of the defective board.
Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs. Monitor can monitor, display, trend and print a patient''s physiological parameters. The device has a 12.1 inch color display and has a standard configuration of a 3 or 5 lead ECG, Masimo SET SpO2, non-invasive blood pressure, respiration, continuous temperature and IV Drug Calculations. Optional digital displays are provided for invasive blood pressure (up to four) anesthetic agents, O2 and NO2, ST, and CO2
Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data.
Datascope sent out a Field Correction notice on 9/7/2005 to all Hospital administrators who have the monitors. This was sent out via certified mail, return receipt requested. A Datascope Service Rep will conduct and document the corrective action during a visit to the customer.
Anestar Anesthesia Delivery System
Failure of the Anestar AC Main Power Switch. Battery should last 30 minutes, then ventilation and monitoring will fail.
A Field Correction action was initiated in June, 2003 and completed by the service reps in April, 2004.
Anestar and Anestar Plus Anesthesia System.
The Anestar and Anestar Plus Anesthesia System may produce periods of high Positive End-Expiratory Pressure (PEEP), in both manual and mechanical ventilation mode due to an issue with the Applied Pressure Limit (APL) valve.
Field correction communications were sent 3/17/2006 to all accounts via certified mail, return receipt requested, signature required.
Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
Software anomaly that affects the Panorama Telepack where if communications are lost during standby, certain alarms which appear set could be actually off.
Datascope sent letters to the distributors and end users on 12/7/2005. This communication states that a Datascope Service Representative will conduct and document the corrective action during a visit to the customer.
Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
The software version contains an anomaly which could freeze the unit when the right click button is used on the mouse.
A recall letter was sent to the consignees on 8/19/2005.
Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.
Upon the new release of software, the firm started receiving reports of unexpected system failures in the database subsystem related to virtual memory pages.
The firm sent a field correction communications to all customers via certified mail on 6/10/2005. A Datascope Service Representative will conduct and document this corrective action during a visit to the customer.
Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate is derived from ECG.
Letter was sent on 9/24/2004 via FedEx to the three customers with proof of delivery required.
Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system.
Potential inaccurate printed information in the upper and lower margins of a print strip.
Datascope initiated this field action in February, 2004. Datascope Service Representatives are visiting the customers and doing the retrofit.
Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
The Trio Monitor has latex feet. It is not labeled per 21 CFR801.437 to indicate that it contains latex.
On July 28, 2004, the firm sent out a Urgent Product Field Correction via FedEx to their customers. Enclosed with this letter was the replacement feet, an Instruction form and a field correction completion form.
10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11'' introducer sheaths. These introducer sheaths include a hemostasis valve and a hub which work in conjunction with an introducer dilator. The introducer sheath, after it is dilated by the introducer dilator, is intended to assist the percutaneous insertion of the 10.5 Fr. Intra-Aortic Balloon catheter into the vasculature.
10.5 Fr. Percor STAT-DL Intra-Aortic Balloon Insertion Kit, Introducer Sheath failed water leak test during final inspection.
Recall letters were sent via US mail return receipt requested to customers on 3/31/2003. Sales representatives received a letter on 3/28/2003.