Recall Z-0177-06 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Datascope Corp
Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physiological monitor designed to monitor and display the following physiological parameters: ECG, Heart Rate derived from selected sources (Sp)2, ECG, IBP and NIBP), SpO2 level, ST Segment, Arrhythmia, Blood pressure (both invasive and non-invasive), Respiration rate (dirived from ECG or CO2), inspired or expire
| Date | Nov 23, 2005 (initiated Sep 7, 2005) |
| Status | Terminated |
| Reason | Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data. |
| Root cause | Other |
| Action | 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. |
| Quantity | 979 monitors |
| Distribution | The monitors have been distributed domestically and internationally to hospitals and clinics. There are 10 Passport 2 monitors distributed to Naval Hospital, Camp Pendleton, CA. There are 12 Spectrum monitors distributed to two US Govt facilities: VA Medical Center, Hines, IL and VA Medical Center |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020550 | PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX Datascope Corp., Aug 28, 2002 |