Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physiological monitor designed to mo
FDA device recall Z-0177-06 · 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
- 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
- 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 |
|---|---|---|
| PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX (K020550) | Datascope Corp. | 2002-08-28 |