Recall Z-0176-06 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Datascope Corp
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 displ
| 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 | 2318 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
| K031849 | SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX Datascope Corp., Sep 9, 2003 |