Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system.
FDA device recall Z-1050-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Datascope Corp
- Reason for recall
- Potential inaccurate printed information in the upper and lower margins of a print strip.
- Action taken
- Datascope initiated this field action in February, 2004. Datascope Service Representatives are visiting the customers and doing the retrofit.
- Root cause
- Other
- Status
- Terminated
- Product code
- MSX
- Quantity affected
- 202
- Distribution
- The units were shipped to hospitals and clinics nationwide. Also to Australia, Brazil, Belgium, France, Germany,Turkey, United Kingdom, United Arab Emirates. One unit was shipped to the VA Medical Cen
- Date initiated
- 2004-04-05
- Date posted
- 2004-07-20
- Date terminated
- 2005-01-19
- 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 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX (K993531) | Datascope Corp. | 2000-01-13 |