Recall Z-1050-04 ยท MSX System, Network And Communication, Physiological Monitors
Datascope Corp
Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system.
| Date | Jul 20, 2004 (initiated Apr 5, 2004) |
| Status | Terminated |
| Reason | Potential inaccurate printed information in the upper and lower margins of a print strip. |
| Root cause | Other |
| Action | Datascope initiated this field action in February, 2004. Datascope Service Representatives are visiting the customers and doing the retrofit. |
| Quantity | 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 Center, Augusta, GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993531 | PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX Datascope Corp., Jan 13, 2000 |