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Terminated

Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system.

FDA Recall Z-1050-04 · Posted 2004-07-20

Recalling FirmDatascope Corp
Recall StatusTerminated
Product CodeMSX
Date Initiated2004-04-05
Date Terminated2005-01-19
Product Quantity202

Reason for Recall

Potential inaccurate printed information in the upper and lower margins of a print strip.

Firm Action

Datascope initiated this field action in February, 2004. Datascope Service Representatives are visiting the customers and doing the retrofit.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993531PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XXDatascope Corp. · 2000-01-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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