Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs. Monitor can monitor, display, tren
FDA device recall Z-0176-06 · posted 2005-11-23 · Terminated
Recall details
- Recalling firm
- Datascope Corp
- Reason for recall
- Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DRT
- Quantity affected
- 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
- Date initiated
- 2005-09-07
- Date posted
- 2005-11-23
- Date terminated
- 2007-06-06
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX (K031849) | Datascope Corp. | 2003-09-09 |